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protocolSection identificationModule nctId: NCT06261333, orgStudyIdInfo id: 23-11519-BO, briefTitle: Quality of Life in Patients With Hemorrhagic Telangiectasia, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-01-22, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Essen, class: OTHER, descriptionModule briefSummary: Hereditary Hemorrhagic Telangiectasia (HHT), also known as Osler's disease, is a genetic disorder that leads to abnormal blood vessel formations. It primarily affects blood vessels in the skin, mucous membranes, and internal organs. The disease can be clinically diagnosed using the Curaçao criteria (1. Positive family history of HHT, 2. Recurrent and spontaneous epistaxis, 3. Multiple typical telangiectasias, 4. Organ involvement with vascular malformations, especially in the liver, lungs, gastrointestinal tract, or brain); if a patient meets at least 3 criteria, the diagnosis of HHT can be established.Patients with HHT often have telangiectasias on their faces. Additionally, many patients suffer from anemia, which can result in a pale and potentially tired appearance. Patients with HHT may be less satisfied with their appearance due to the aesthetic changes in their faces and may also experience psychosocial impairment. To further investigate this, various validated questionnaires (FACE-Q©, PROMIS-Profile-29+2, EQ5D), as well as routinely collected clinical data (e.g., laboratory values including hemoglobin levels, Curaçao criteria, smoking status, alcohol consumption, and the Epistaxis Severity Score (ESS)) will be used., conditionsModule conditions: Hereditary Hemorrhagic Telangiectasia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Questionnaires, outcomesModule primaryOutcomes measure: Quality of Life and Patient Satisfaction measured using the FACE-Questionnaire, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Departement of Otorhinolaryngology - Head and Neck Surgery University Hospital Essen, city: Essen, state: NRW, zip: 45147, country: Germany, geoPoint lat: 51.45657, lon: 7.01228, hasResults: False

protocolSection identificationModule nctId: NCT06261320, orgStudyIdInfo id: 2023-506950-18-00, briefTitle: Mesotherapy Treatment of Irritable Bowel Syndrome, acronym: MESOCOLO, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-12-31, completionDateStruct date: 2026-01-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Polyclinique de l'Europe, class: OTHER, descriptionModule briefSummary: Irritable bowel syndrome (IBS) is a gastrointestinal transit disorder characterized by chronic abdominal pain and impaired transit in the absence of demonstrated organic disease. Considered a non-fatal disease, its effects relate more to quality of life, work production and health care systems.Given the complexity of this disease, no treatment has been recognized as standard treatment. The treatment is rather focused on treating the symptoms caused (chronic pain or intestinal transit disorder). In general, therapy is considered individualized and includes lifestyle/diet modifications and pharmaceutical therapy.Several published case studies evaluating the effect of mesotherapy on improving the severity of the disease have demonstrated an improvement in the symptoms of this syndrome. Due to the limited number of case studies and the insufficient level of evidence to conclude, our study will therefore be a before-and-after intervention study, to evaluate the effect of four mesotherapy sessions on the treatment of IBS symptoms., conditionsModule conditions: Inflammatory Bowel Diseases, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 27, type: ACTUAL, armsInterventionsModule interventions name: Mesotherapy with mesocaine, thiocolchicoside, amitriptyline, magnesium pidolate, outcomesModule primaryOutcomes measure: Irritable Bowel Syndrome Symptom Severity Scale(IBS-SSS), secondaryOutcomes measure: Functional Digestive Disorders Quality of Life questionnaire (FDDQL), secondaryOutcomes measure: Pain evaluation, secondaryOutcomes measure: Global satisfaction, secondaryOutcomes measure: Anxiety evaluation : Questionnaire "Hospital anxiety and depression scale", eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Polyclinique de l'Europe, city: Saint-Nazaire, zip: 44600, country: France, geoPoint lat: 47.28333, lon: -2.2, hasResults: False

protocolSection identificationModule nctId: NCT06261307, orgStudyIdInfo id: 13462111, briefTitle: Language Development Deficits and Early Interactive Music Intervention, acronym: BusyBaby, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-11, primaryCompletionDateStruct date: 2026-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Helsinki, class: OTHER, collaborators name: Folkhälsan Research Center, collaborators name: Karolinska Institutet, collaborators name: University of Turku, collaborators name: University of Jyvaskyla, collaborators name: Academy of Finland, descriptionModule briefSummary: Investigators compare effects of 6-month music versus circus group interventions on language development in infants and toddlers with or without familial risk for dyslexia (anticipated total N=200). Effects of intervention timing, dyslexia risk and genetics, and social-emotional factors on the intervention outcomes are investigated., conditionsModule conditions: Dyslexia, Developmental, conditions: Language Development Disorders, conditions: Language Development, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The experimental arm will receive music training and the control arm will receive circus training., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: A dedicated member of the research team will be in charge of randomization of the participants to the two intervention arms, to ensure blindness of other team members. This member will not act as an outcomes assessor or a care provider.The study will be presented to the caregivers as evaluating the effect of hobbies on language development. Therefore, the caregivers should not consider either intervention as the control arm. Both arms are expected to be potentially beneficial for the children's development.Outcomes assessors will be unaware of the intervention arm and risk status (dyslexia risk vs no risk) of the children; caregivers will be reminded not to mention these to the researcher. Person in charge of randomization keeps track of violations of outcome assessor blindness., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 200, type: ESTIMATED, armsInterventionsModule interventions name: Music intervention, interventions name: Circus intervention, outcomesModule primaryOutcomes measure: Infant-Toddler Checklist (ITC), primaryOutcomes measure: MacArthur-Bates Communicative Development Inventory (MCDI) 8-16mo, primaryOutcomes measure: Mismatch response (MMR) speech, amplitude, primaryOutcomes measure: Mismatch response (MMR) speech, latency, primaryOutcomes measure: Mismatch response (MMR) speech, laterality, primaryOutcomes measure: Obligatory event-related potential (ERP) speech, amplitude, primaryOutcomes measure: Obligatory event-related potential (ERP) speech, latency, primaryOutcomes measure: Obligatory event-related potential (ERP) speech, laterality, secondaryOutcomes measure: Infant-Toddler Checklist (ITC) follow-up, secondaryOutcomes measure: MacArthur-Bates Communicative Development Inventory (MCDI) 16-30mo follow-up, secondaryOutcomes measure: Mismatch response (MMR) speech, amplitude follow-up, secondaryOutcomes measure: Mismatch response (MMR) speech, latency follow-up, secondaryOutcomes measure: Mismatch response (MMR) speech, laterality follow-up, secondaryOutcomes measure: Obligatory event-related potential (ERP) speech, amplitude follow-up, secondaryOutcomes measure: Obligatory event-related potential (ERP) speech, latency follow-up, secondaryOutcomes measure: Obligatory event-related potential (ERP) speech, laterality follow-up, secondaryOutcomes measure: Reynell Developmental Language Scales III (RDLS-III), secondaryOutcomes measure: Infant Behavior Questionnaire Revised short form (IBQ-R-sf), secondaryOutcomes measure: Early Childhood Behavior Questionnaire short form (ECBQ-sf), secondaryOutcomes measure: Parenting Stress Index Short Form (PSI-sf), secondaryOutcomes measure: Brief Infant-Toddler Social Emotional Assessment (BITSEA), otherOutcomes measure: Parental dyslexia status (dyslexia - no dyslexia), otherOutcomes measure: Allele groupings for dyslexia susceptibility genes, otherOutcomes measure: Gross and fine motor development, otherOutcomes measure: Bayley Scales III Motor scale, otherOutcomes measure: Mismatch response (MMR) music, amplitude, otherOutcomes measure: Mismatch response (MMR) music, latency, otherOutcomes measure: Mismatch response (MMR) music, laterality, otherOutcomes measure: Obligatory event-related potential (ERP) music, amplitude, otherOutcomes measure: Obligatory event-related potential (ERP) music, latency, otherOutcomes measure: Obligatory event-related potential (ERP) music, laterality, otherOutcomes measure: Music test scores (three parts of MMBB-MB), otherOutcomes measure: Music-related activities, otherOutcomes measure: Musical background of parents, otherOutcomes measure: Home literacy, otherOutcomes measure: Multilingualism, otherOutcomes measure: Screen time, eligibilityModule sex: ALL, minimumAge: 8 Months, maximumAge: 12 Months, stdAges: CHILD, contactsLocationsModule locations facility: University of Helsinki, status: RECRUITING, city: Helsinki, zip: 00014, country: Finland, contacts name: Paula Virtala, PhD, role: CONTACT, phone: +358408446907, email: paula.virtala@helsinki.fi, geoPoint lat: 60.16952, lon: 24.93545, hasResults: False

protocolSection identificationModule nctId: NCT06261294, orgStudyIdInfo id: CPIP-LUN-A001, briefTitle: OncoSweep Cancer Spotlight and Spectrum Product Line, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-05-23, primaryCompletionDateStruct date: 2025-03-20, completionDateStruct date: 2026-03-20, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Pharus Taiwan, Inc., class: INDUSTRY, descriptionModule briefSummary: CONQUER cancer study: To collect blood samples from cancer and non-cancer participants for development and validation of the 'OncoSweep Cancer Spotlight and Spectrum Product Line', conditionsModule conditions: Lung Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: PROSPECTIVE, enrollmentInfo count: 800, type: ESTIMATED, armsInterventionsModule interventions name: OncoSweep Lung Spotligh, outcomesModule primaryOutcomes measure: To differentiate lung cancer signals from non-cancer signals based on analysis of OncoSweep Lung Spotlight., eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mackay Memorial Hospital, status: RECRUITING, city: Taipei, state: Zhongshan Dist, zip: 104217, country: Taiwan, contacts name: Sheng-Hsiung Yang, role: CONTACT, phone: +886 2 2543-3535, email: lazatemax@gmail.com, geoPoint lat: 25.04776, lon: 121.53185, hasResults: False

protocolSection identificationModule nctId: NCT06261281, orgStudyIdInfo id: TBI cancel, briefTitle: Effect of Intermittent Oro-esophageal Tube Feeding on Severe Traumatic Brain Injury Patient, acronym: IOE-TBI, statusModule overallStatus: WITHDRAWN, startDateStruct date: 2024-02-10, primaryCompletionDateStruct date: 2024-07-10, completionDateStruct date: 2024-07-10, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-06, sponsorCollaboratorsModule leadSponsor name: Zeng Changhao, class: OTHER, descriptionModule briefSummary: This was a multicenter randomized controlled study of 98 severe Traumatic Brain Injury patients with tracheostomy. Patients enrolled were divided randomly into the observation group with Intermittent Oro-esophageal Tube Feeding or the control group with Nasogastric tube feeding for enteral nutrition support, respectively. Nutritional status, complications, decannulation of tracheostomy tubes and level of consciousness on day 1 and day 28 were recorded and compared., conditionsModule conditions: Traumatic Brain Injury, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 0, type: ACTUAL, armsInterventionsModule interventions name: Rehabilitation therapy, interventions name: Intermittent Oro-esophageal Tube Feeding, interventions name: Nasogastric tube feeding, outcomesModule primaryOutcomes measure: Concentration of hemoglobin, primaryOutcomes measure: Concentration of albumin, primaryOutcomes measure: Concentration of prealbumin, primaryOutcomes measure: Nutritional status-body mass index, secondaryOutcomes measure: Decannulation of tracheostomy tube-placement duration, secondaryOutcomes measure: Decannulation of tracheostomy tube-Successful removal, secondaryOutcomes measure: Level of consciousness, secondaryOutcomes measure: Feeding Amount, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Zheng Da yi Yuan Hospital, city: Zhengzhou, state: Henan, zip: 450000, country: China, geoPoint lat: 34.75778, lon: 113.64861, hasResults: False

protocolSection identificationModule nctId: NCT06261268, orgStudyIdInfo id: Strip vs FGG, briefTitle: Strip Graft w/ Xenogeneic Matrix vs Free Gingival Graft for the Augmentation of Peri-implant Keratinized Mucosa, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-29, primaryCompletionDateStruct date: 2024-12-15, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universidad Complutense de Madrid, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to compare changes in peri-implant keratinized mucosa (PIKM) following the application of apically repositioned flap (ARF) using a combination of a Strip graft and a Xenogeneic matrix, or with a free gingival graft (FGG), in implants in the second stage with \<2 mm of PIKM.Additionally, as a secondary objective, the investigators compare postoperative blood supply in both recipient and donor sites based on the type of graft obtained. Meanwhile, the investigators evaluate differences between the two groups concerning microcirculation values (perfusion units, PU), soft tissue thickness (STT), volume change, vestibular depth, as well as clinical, aesthetic, and patient-reported outcome measures (PROMS)., conditionsModule conditions: Peri-Implantational Loss, conditions: Surgical Wound, conditions: Healing Surgical Wounds, conditions: Thin-gingiva, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: A randomized controlled equivalence clinical trial will be performed, with two parallel groups, a 1:1 allocation ratio, and a 12-month follow-up., primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Strip graft with Mucograft, interventions name: Free gingival graft, outcomesModule primaryOutcomes measure: Changes in peri-implant keratinized mucosa width (mm), secondaryOutcomes measure: Vascularization (in Laser Speckle perfusion units [LSPU]), secondaryOutcomes measure: Changes in soft tissue thickness (STT) (mm), secondaryOutcomes measure: Vestibule depth (VD) (mm), secondaryOutcomes measure: Probing pocket depth (PPD) (mm), secondaryOutcomes measure: Dehiscence (mm), secondaryOutcomes measure: Full-mouth plaque score (FMPS), secondaryOutcomes measure: Volumetric changes, secondaryOutcomes measure: Patient reported outcome measures (PROMS), secondaryOutcomes measure: Esthetic analysis, secondaryOutcomes measure: Intra-surgical parameters, secondaryOutcomes measure: Intra-surgical time, secondaryOutcomes measure: Demographic data, secondaryOutcomes measure: Anamnesis data, secondaryOutcomes measure: Smoking habit, secondaryOutcomes measure: Full-mouth bleeding score (FMBS) (%), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Complutense University, status: RECRUITING, city: Madrid, zip: 28040, country: Spain, contacts name: Mariano Sanz Alonso, role: CONTACT, phone: 913942021, email: marsan@ucm.es, contacts name: Andrea Dobos, DMD, role: SUB_INVESTIGATOR, contacts name: David Palombo, DMD, role: SUB_INVESTIGATOR, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False

protocolSection identificationModule nctId: NCT06261255, orgStudyIdInfo id: ATT_CS, briefTitle: Autotransplantation and Enamel Matrix Derivatives Case Series, acronym: ATTCS, statusModule overallStatus: COMPLETED, startDateStruct date: 2020-06-01, primaryCompletionDateStruct date: 2023-09-01, completionDateStruct date: 2023-12-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universidad Complutense de Madrid, class: OTHER, descriptionModule briefSummary: The goal of this prospective case series is to compare the adjunctive use of enamel matrix derivatives in the treatment of tooth autotransplantation in terms of clinical attachment level.The main question it aims to answer is:- What is the benefit, in terms of clinical attachment level, of using enamel matrix derivatives adjunctive to tooth autotransplantation?Participants will be subjected to a digitally protocol of tooth autotransplantation.Only one group (test) is assessed. It will be supplemented with the application of enamel matrix derivatives before the placement of the transplanted tooth into the surgically produced alveolus., conditionsModule conditions: Tooth Loss, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: This clinical investigation is a single-center, prospective case series study and is reported in compliance with the Preferred Reporting of Case Series in Surgery (PROCESS) guidelines. The study was conducted at the Department of Periodontology of the University Complutense of Madrid between March 2021 and September 2023., primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 14, type: ACTUAL, armsInterventionsModule interventions name: ATT + EMD, outcomesModule primaryOutcomes measure: Clinical attachment level (CAL), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Universidad Complutense de Madrid, city: Madrid, zip: 28003, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, locations facility: Universidad Complutense Madrid, city: Madrid, country: Spain, geoPoint lat: 40.4165, lon: -3.70256, hasResults: False

protocolSection identificationModule nctId: NCT06261242, orgStudyIdInfo id: TWM-C-2201, briefTitle: Tripod-Fix Vertebral Body Augmentation System in Osteoporotic Vertebral Compression Fractures Treatment, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-16, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-07-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: National Cheng-Kung University Hospital, class: OTHER, descriptionModule briefSummary: This study is to evaluate the safety and effectiveness of the Tripod-Fix with Tecres Mendec® Spine HV System to treat subjects with osteoporotic vertebral compression fractures., conditionsModule conditions: Osteoporotic Vertebral Compression Fractures, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: Tripod-Fix Vertebral Body Augmentation System (Tripod-Fix), outcomesModule primaryOutcomes measure: Proportion of participants with study success, eligibilityModule sex: ALL, minimumAge: 50 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cheng Kung University Hospital Department of Orthopedics, status: RECRUITING, city: Tainan, zip: 704, country: Taiwan, contacts name: Susan Guo, role: CONTACT, phone: +8666-2353535, phoneExt: 3690, contacts name: Cheng-Li Lin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 22.99083, lon: 120.21333, hasResults: False

protocolSection identificationModule nctId: NCT06261229, orgStudyIdInfo id: MURA2022/230, briefTitle: The Effectiveness of Intermittent Fasting and Behavioral Economics Intervention on Weight Control in Obese Patients, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2022-04-18, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Mahidol University, class: OTHER, collaborators name: Health Systems Research Institute, descriptionModule briefSummary: This study is a parallel randomized controlled trial (RCT). To determine the effect of intermittent fasting, intermittent fasting with behavioral economics, and intensive lifestyle modification on nutritional status; the differences between HOMA-IR, body weight change, and body composition in obese people.Each participant will be randomized to receive the intervention (intermittent fasting, intermittent fasting with behavioral economics, or intensive lifestyle modification.The study protocol will be explained to the eligible participant and informed written consent will be obtained.The total sample size will be 123 participants. Blood and urine samples will be collected at baseline and each follow-up visit including 1-month, 2-months, 6-month, and 12-months, respectively for further study to find out the mechanisms of weight loss, weight regain, and the improvement in the metabolic disease., conditionsModule conditions: Intermittent Fasting, conditions: Weight Loss, conditions: Behavioral Economic, conditions: Obese, conditions: HOMA-IR, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 123, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent fasting, interventions name: Intermittent fasting + Behavioral economic, interventions name: Intensive Lifestyle Modification, outcomesModule primaryOutcomes measure: HOMR-IR (index), primaryOutcomes measure: Body mass index (kg/m^2), secondaryOutcomes measure: FBS (mg/dl), secondaryOutcomes measure: HbA1C (%), secondaryOutcomes measure: Albumin (g/L), secondaryOutcomes measure: Creatinine (mg/dL), secondaryOutcomes measure: Alanine transaminase (ALT) U/L, secondaryOutcomes measure: Aspartate transaminase (AST) U/L, secondaryOutcomes measure: Uric acid (mg/dL), secondaryOutcomes measure: Total cholesterol (mg/dL), secondaryOutcomes measure: HDL-C (mg/dL), secondaryOutcomes measure: LDL-C (mg/dL), secondaryOutcomes measure: Triglycerides (mg/dL), secondaryOutcomes measure: Blood Urea Nitrogen (BUN) (mg/dL), secondaryOutcomes measure: Urine albumin-creatinine ratio (UACR) (mg/g), secondaryOutcomes measure: Energy from food (kilocalories), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mahidol University, city: Ratchathewi, state: Bangkok, zip: 10400, country: Thailand, geoPoint lat: 13.759, lon: 100.53358, hasResults: False

protocolSection identificationModule nctId: NCT06261216, orgStudyIdInfo id: 01/2023/LPA-wtATTR/NVNS, briefTitle: Association Between Lifetime Physical Activity and Exercise and the Development of Wild-type Transthyretin Amyloid Cardiomyopathy, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Medical University of Graz, class: OTHER, collaborators name: Medical University Innsbruck, descriptionModule briefSummary: The aim of this study is to investigate the association between increased lifetime physical activity and the development of wild-type transthyretin amyloid cardiomyopathy., conditionsModule conditions: Amyloid Cardiomyopathy, conditions: Wild Type ATTR Amyloidosis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 252, type: ESTIMATED, armsInterventionsModule interventions name: Interview, outcomesModule primaryOutcomes measure: Association between lifetime physical activity and disease development, secondaryOutcomes measure: Association between lifetime athletic activity and disease development, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Medical University of Graz, status: RECRUITING, city: Graz, country: Austria, contacts name: PI, role: CONTACT, phone: 0043 316 385 30173, email: nicolas.verheyen@medunigraz.at, contacts name: Nicolas Verheyen, MD PhD, role: PRINCIPAL_INVESTIGATOR, contacts name: Nora Schwegel, MD, role: SUB_INVESTIGATOR, geoPoint lat: 47.06667, lon: 15.45, hasResults: False

protocolSection identificationModule nctId: NCT06261203, orgStudyIdInfo id: Hany Hosny, briefTitle: Low Dose Aspirin for Prevention of Early Pregnancy Loss, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-07-01, primaryCompletionDateStruct date: 2025-07-01, completionDateStruct date: 2025-07-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Egymedicalpedia, class: INDUSTRY, descriptionModule briefSummary: Preeclampsia is a pregnancy-specific, multisystem disorder affecting 3% to 8% of pregnancies and remains a significant cause of maternal and neonatal morbidity and mortality worldwide.The World Health Organization estimates that approximately 76,000 maternal deaths annually are attributed to preeclampsia, accounting for 16% of global maternal mortality, with the majority occurring in low- and middle-income countries, conditionsModule conditions: Pre-Eclampsia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The The study's findings have the potential to clarify aspirin's role in preventing adverse pregnancy outcomes related to placental dysfunction and improve the management of women at risk of placental-mediated complications., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 250, type: ESTIMATED, armsInterventionsModule interventions name: Aspirin, outcomesModule primaryOutcomes measure: Prevention of pregnancy loss, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Assuit University hospitals, status: RECRUITING, city: Asyūţ, state: Assuit, country: Egypt, contacts name: Mohamed Nagy, Lecturer, role: CONTACT, phone: 01096655458, email: drmnagy@aun.edu.eg, contacts name: Abdelrahman Mahmoud, Assist.Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False

protocolSection identificationModule nctId: NCT06261190, orgStudyIdInfo id: H-2308-182-1463, briefTitle: Active Surveillance for Low-risk Papillary Thyroid Carcinoma, acronym: MAeSTroⅡ, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-04, primaryCompletionDateStruct date: 2029-12-31, completionDateStruct date: 2032-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: National Cancer Center, Korea, class: OTHER_GOV, collaborators name: Seoul National University Bundang Hospital, collaborators name: SMG-SNU Boramae Medical Center, collaborators name: Seoul National University Hospital, descriptionModule briefSummary: This study is an observational cohort study targeting patients with low-risk Papillary thyroid cancer who opted for active surveillance or immediate surgery based on a sufficient understanding of the treatment options. The primary objective of the study is to evaluate progression free survival of the patients with low-risk Papillary thyroid cancer who choose active surveillance, in other words, to observe the natural course of low-risk Papillary thyroid cancer., conditionsModule conditions: Thyroid Cancer, conditions: Papillary Thyroid Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 499, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Progression free survival of the patients with low-risk Papillary Thyroid Cancer who choose Active Surveillance, secondaryOutcomes measure: Disease progression, secondaryOutcomes measure: Rate of Participants in the Active Surveillance Group that change to surgery without disease progression, secondaryOutcomes measure: Comparison of Quality of Life between the Active Surveillance group and immediate surgery group, secondaryOutcomes measure: Measure of Anxiety and Depression, secondaryOutcomes measure: Measure of Satisfaction with the treatment, secondaryOutcomes measure: Factors influencing patients' decisions regarding disease management, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: National Cancer Center, city: Goyang-si, country: Korea, Republic of, contacts name: Eun Kyung Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.65639, lon: 126.835, locations facility: Seoul National University Bundang Hospital, city: Seongnam, country: Korea, Republic of, contacts name: Jae Hoon Moon, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Seoul National University Hospital, city: Seoul, country: Korea, Republic of, contacts name: Young Joo Park, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, locations facility: SMC-SNU Boramae Medical Center, city: Seoul, country: Korea, Republic of, contacts name: Ka Hi Lee, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06261177, orgStudyIdInfo id: 22-175, briefTitle: Take-home Functional Electrical Stimulation for MDD, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-12-04, primaryCompletionDateStruct date: 2024-12, completionDateStruct date: 2025-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Unity Health Toronto, class: OTHER, descriptionModule briefSummary: The purpose of this study is to learn whether Functional Electrical Stimulation (FES) of the facial muscles is effective in treating major depressive disorder (MDD) and to develop a model for take-home delivery., conditionsModule conditions: MDD, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, maskingDescription: Double-blind, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ACTUAL, armsInterventionsModule interventions name: Functional Electrical Stimulation (FES), interventions name: Sham FES, outcomesModule primaryOutcomes measure: Feasibility of the FES for MDD, primaryOutcomes measure: Tolerability and safety of the FES for MDD, secondaryOutcomes measure: Improvement in symptoms of depression-17-item Hamilton Depression Rating Scale (HAM-D-17), secondaryOutcomes measure: Improvement in symptoms of depression-16-Item Quick Inventory of Depressive Symptomatology-Self Report (QIDS-SR-16), secondaryOutcomes measure: Improvement in symptoms of anxiety- General Anxiety Disorder (GAD-7), secondaryOutcomes measure: Improvement in well-being-World Health Organization-5 Well-Being Index (WHO-5), secondaryOutcomes measure: Improvement in sleep quality- Pittsburgh Sleep Quality Index (PSQI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: St. Michael's Hospital, city: Toronto, state: Ontario, country: Canada, geoPoint lat: 43.70011, lon: -79.4163, hasResults: False

protocolSection identificationModule nctId: NCT06261164, orgStudyIdInfo id: 01-19-373- 2/23, briefTitle: Population Pharmacokinetic Model of Amikacin and Vancomycin in Critically Ill Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-31, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-01-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University Clinical Centre of Republic of Srpska, class: OTHER, descriptionModule briefSummary: The object of the scientific research is the characterization of the pharmacokinetic profile and the investigation of factors of pharmacokinetic variability of amikacin and vacnomycin in critically ill patients with a diagnosis of sepsis-like condition (SIRS), hospital-acquired sepsis and/or septic shock and who are on extracorporeal therapy with Cytosorb® and Oxiris® adsorbents., conditionsModule conditions: Sepsis, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Cytosorb® and Oxiris® adsorbents, outcomesModule primaryOutcomes measure: Development of population pharmacokinetic model, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Medical Intensive Care Medicine, status: RECRUITING, city: Banja Luka, zip: 78000, country: Bosnia and Herzegovina, contacts name: Nikolina Spiric, MPharm, role: CONTACT, phone: +38751342295, email: nikolina.spiric@kc-bl.com, contacts name: Pedja Kovacevic, Prof., role: SUB_INVESTIGATOR, geoPoint lat: 44.77842, lon: 17.19386, hasResults: False

protocolSection identificationModule nctId: NCT06261151, orgStudyIdInfo id: Zhongshan-HHY-03, briefTitle: Preoperative Nutritional Status Associated With Delayed Discharge in Elderly Patients Undergoing Gastrectomy, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Shanghai Zhongshan Hospital, class: OTHER, descriptionModule briefSummary: Gastric cancer (GC) remains the 5th most common cancer worldwide and had the second- highest mortality rate in China. The population of elder patients with GC has been increasing because of the high prevalence of H. pylori infection and increasing life expectancy. Elderly GC patients face several challenges during treatment, such as comorbidities, organ dysfunction, immunosuppression, and delayed recovery. Advanced age is associated with a higher rate of postoperative complications shortly after surgical treatment, and lower 5-year overall survival as long-term outcome.In China, the prevalence of malnutrition in hospitalized patients is around 12.6% to 46.19%. Malnutrition is one of the great risk factors of adverse clinical outcomes in elderly patients with GC. The nutritional status at the time of diagnosis was independently associated with postoperative complications, overall survival, and disease-free survival. The condition can be caused by mechanical obstruction of the digestive tract or anorexia-cachexia syndrome, leading to insufficient protein or energy intake and absorption disorder. Nutrition screening, assessment, and intervention are important steps in nutritional management.Previous studies mostly focused on hospitalized internal medical patients. Only a few studies focused on surgical patients regardless of age. Therefore, in this retrospective study, we are going to investigate the nutritional status and perioperative nutritional support of geriatric surgical patients with GC, and provide a basis for implementing an effective nutritional intervention., conditionsModule conditions: Preoperative Nutritional Status and Risk Factors Associated With Elderly Patients Undergoing Gastrectomy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 1000, type: ESTIMATED, armsInterventionsModule interventions name: Clinical data collection, outcomesModule primaryOutcomes measure: The preoperative nutritional status of elderly patients underwent gastrectomy, eligibilityModule sex: ALL, minimumAge: 60 Years, maximumAge: 90 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06261138, orgStudyIdInfo id: RSR-HCC-2019-001, briefTitle: Survival Analysis: TACE vs. Combination Therapy in HCC, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2023-10-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Zhejiang University, class: OTHER, descriptionModule briefSummary: This retrospective observational study aimed to assess potential improvements associated with systemic therapies in patients receiving transarterial chemoembolization (TACE) for initially unresectable HCC., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 279, type: ACTUAL, armsInterventionsModule interventions name: Transarterial chemoembolization, interventions name: Systemic treatment, outcomesModule primaryOutcomes measure: Progression Free Survival (PFS) per mRECIST, secondaryOutcomes measure: 12 months PFS rate, secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Objective Response Rate (ORR) per mRECIST, secondaryOutcomes measure: Disease Control Rate (DCR) per mRECIST, secondaryOutcomes measure: Adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: First Affiliated Hospital, Medical College of Zhejiang University, city: Hangzhou, state: Zhejiang, zip: 310003, country: China, geoPoint lat: 30.29365, lon: 120.16142, hasResults: False

protocolSection identificationModule nctId: NCT06261125, orgStudyIdInfo id: SL-B2023-718, briefTitle: Combination of SBRT, PD-L1 Inhibitor, and Lenvatinib in Hepatocellular Carcinoma (HSBRT2401), acronym: HSBRT2401, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-10, primaryCompletionDateStruct date: 2026-06-30, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-12, sponsorCollaboratorsModule leadSponsor name: Mian XI, class: OTHER, descriptionModule briefSummary: Abdominal lymph node metastasis (LNM) is one of the major modes of extrahepatic metastasis in hepatocellular carcinoma (HCC). Immunotherapy targeting the PD-1/PD-L1 checkpoints combined with targeted therapy is the standard treatment for HCC with abdominal LNM, but the outcome remains very poor, with an objective response rate of 5% to 30%. Previous studies have demonstrated that stereotactic body radiotherapy (SBRT) is an effective local treatment for HCC with abdominal LNM, with a high response rate of 60% to 80%. However, intrahepatic dissemination and distant metastasis remains the major recurrence pattern after SBRT in these patients, suggesting radiotherapy should be combined with systematic treatment. Recently, the combination of immunotherapy with SBRT has shown promising activity in HCC. The aim of this study was to investigate the efficacy and safety of SBRT followed by adebrelimab (an anti-PD-L1 antibody) and lenvatinib in HCC patients with portal abdominal LNM., conditionsModule conditions: Hepatocellular Carcinoma, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Stereotactic body radiotherapy, interventions name: Adebrelimab, interventions name: Lenvatinib, outcomesModule primaryOutcomes measure: Progression-free survival (PFS), secondaryOutcomes measure: Overall survival (OS), secondaryOutcomes measure: Overall response rate (ORR), secondaryOutcomes measure: Disease control rate (DCR), secondaryOutcomes measure: Duration of response (DOR), secondaryOutcomes measure: Treatment-related adverse events, otherOutcomes measure: Correlation between serum cytokines and overall survival and immune-related adverse events, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mian Xi, status: RECRUITING, city: Guangzhou, state: Guangdong, zip: 510060, country: China, contacts name: Mian Xi, MD, role: CONTACT, phone: +862087343385, email: ximian@sysucc.org.cn, contacts name: Mian Xi, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 23.11667, lon: 113.25, hasResults: False

protocolSection identificationModule nctId: NCT06261112, orgStudyIdInfo id: B.30.2.ATA.01.11/285, briefTitle: The Effect of Using a Kaleidoscope on Fear and Pain in Children, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-07, primaryCompletionDateStruct date: 2024-05-01, completionDateStruct date: 2024-05-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Mihriban Culha, class: OTHER, descriptionModule briefSummary: The research was conducted in randomized controlled experimental type between May 2022 and December2023. The universe of the research consisted of children and their parents who were diagnosed with a fracture, applied to the Orthopedic outpatient clinic and Emergency department of the Erzurum Ataturk University Health Research and Application Center and referred to the Orthopedic clinic, and decided to undergo a cast procedure for treatment. The sample of the research consisted of a total of 70 children and their parents, including 35 control groups and 35 kaleidoscope groups, who met the research criteria from this universe. The children in the kaleidoscope group were shown the kaleidoscope. No intervention other than routine application was applied to the control group. "Introductory Information Form", "Wong-Baker Facial Expressions Rating Scale and Child Fear Scale were used in the collection of data., conditionsModule conditions: Fracture; Complication Orthopedic Procedure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel Assigment, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: SINGLE, maskingDescription: single /investigatör), whoMasked: INVESTIGATOR, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: kaleidescope, outcomesModule primaryOutcomes measure: Child Fear Scale (CFS), secondaryOutcomes measure: Facial Expressions Rating Scale, eligibilityModule sex: ALL, minimumAge: 6 Years, maximumAge: 12 Years, stdAges: CHILD, contactsLocationsModule locations facility: Ataturk University, status: RECRUITING, city: Erzurum, zip: 25240, country: Turkey, contacts name: Mihriban ÇULHA, role: CONTACT, phone: 05070926243, email: mihriban2560@outlook.com, geoPoint lat: 39.90861, lon: 41.27694, hasResults: False

protocolSection identificationModule nctId: NCT06261099, orgStudyIdInfo id: 037, briefTitle: Telerehabilitation-Based Early Upper Extremity Training in Stroke Patients, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-08, primaryCompletionDateStruct date: 2025-02-27, completionDateStruct date: 2025-11-27, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Suleyman Demirel University, class: OTHER, descriptionModule briefSummary: Telerehabilitation method, which is an alternative to face-to-face rehabilitation practices for stroke patients who need intensive, regular and long-term rehabilitation in the early period, has been popularly used in recent years. Telerehabilitation is a practice in which the patient participates in the treatment via digital media without the need for the patient to come to the clinic., conditionsModule conditions: Stroke, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: prospective double-blind, randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, maskingDescription: Sealed envelopes will be prepared in advance for randomization and will be marked with numbers 1 and 2, indicating whether they are a study group or a control group. Randomization will be done by a third party unaware of the study content. Randomization order tracking will be done with sequentially numbered containers. Patients participating in the study will be blinded to which treatment group they will be included in., whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: control + working group, outcomesModule primaryOutcomes measure: Mini Mental Test, primaryOutcomes measure: Fugl Meyer Motor Function Scale, primaryOutcomes measure: Laser-pointer Assisted Angle Reproduction Test, primaryOutcomes measure: Modified Barthel Index, primaryOutcomes measure: Reaching Performance Scale, eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Güler Ertuğrul, status: RECRUITING, city: Kocaeli, state: İ̇zmi̇t, country: Turkey, contacts name: GÜLER ERTUĞRUL, role: CONTACT, phone: +90 531 950 05 90, email: gertugrul004@gmail.com, geoPoint lat: 39.62497, lon: 27.51145, locations facility: Suleyman Demirel University, status: RECRUITING, city: Isparta, state: Merkez, country: Turkey, contacts name: MEHMET DURAY, role: CONTACT, phone: +90 506 473 11 65, email: mehmetduray@sdu.edu.tr, geoPoint lat: 37.76444, lon: 30.55222, hasResults: False

protocolSection identificationModule nctId: NCT06261086, orgStudyIdInfo id: soh-med-24-01-06MS, briefTitle: Evaluation of Pyroptosis-related Indicators in the Pathogenesis of Vitiligo:Across-sectional Comparative Study, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-24, primaryCompletionDateStruct date: 2024-08-24, completionDateStruct date: 2024-08-24, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Vitiligo is an acquired pigmentary disorder on skin and/or mucosae, which is characterized by death of melanocytes (MCs), affecting 0.5%-2% of the population worldwide (1). It doesn't affect the health of patients but it has marked social pressure and greatly interfere with their quality of life (2,3). It presents with well circumscribed milky white patches that occur secondary to destruction of melanocyte, it may appear at any age and affect both sexes equally.It can affect ethnic groups and people of all skin types with no predilection (4).Clinically, several types of vitiligo are distinguished according to the distribution of the achromic lesions. One or more lesions in a dermatomal pattern are characteristic for segmental vitiligo (SV) while this segmental distribution is absent in non-segmental vitiligo (NSV). The latter variety includes both the focal type and the generalized type (5). Numerous previous studies tried to illustrate the pathogenesis behind the disease, but the exact pathophysiology is still not fully understood. It is a multifactorial disease. Factors include, neural theory, oxidative stress theory, autoimmune hypothesis, intrinsic theory, melanocytorrhagy hypothesis (6). Many theories tried to explain the mechanisms of MC destruction in vitiligo. Apoptosis is one of the most widely studied cell death pathways. In addition, the other two forms of cell death, conventional necrosis and autophagy seem to be involved in the death of vitiligo MCs under certain situations. Moreover, new types of regulated cell death including necroptosis, pyroptosis, and ferroptosis may also participate in the pathogenesis (7). Pyroptosis is a highly inflammatory form of necrosis cell death NCD regulated mainly by caspase-1, which is initiated following large supramolecular complex ermed inflammasome activation (8). The inflammasome-activated Caspases then cleave the pyroptosis-inducing protein Gasdermin D (GSDMD), which forms a pore in the plasma membrane and causes cell lysis as well as the secretion of IL-1β typically (9). Another study suggests that inflammasome activation could be a useful marker for assessing disease progression of vitiligo (10). However, the link between vitiligo and inflammasome activation is still unclear. The inflammasome regulates cell death and inflammation via activation of caspase-1 (11). The activation of caspase-1 promotes the secretion of proinflammatory cytokines IL-1β and IL-18, as well as the initiation of pyroptosis (12). So, evaluation of pyroptosis-related indicators (GASDM-D, IL 1β \& IL-18) may help understanding the obscure inflammasome pathway involvement in the pathogenesis of Vitiligo., conditionsModule conditions: Vitiligo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: evaluate serum levels pyroptosis-related indicators (GASDM-D, IL 1β & IL-18), outcomesModule primaryOutcomes measure: GASDM-D, primaryOutcomes measure: IL 1β, primaryOutcomes measure: IL-18, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261073, orgStudyIdInfo id: Soh-Med-24-01-08MS, briefTitle: Evaluation of Serum and Tissue Cathepsin L in Non-segmental Vitiligo Patients, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-01, completionDateStruct date: 2025-03-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Introduction Vitiligo is an autoimmune disease of the skin that targets pigment producing melanocytes and results in patches of depigmentation that are visible as white spots (Frisoli et al., 2020) Vitiligo is a relatively common acquired pigmentation disorder that can cause significant psychological stress (Leung AKC et al., 2021). The disease affects both genders equally, it can appear at any age, and the average age of onset is somewhat variable in different geographic (Majumder et al, 1993), with an estimated prevalence of 0.5-2% of the population in both adults and children worldwide (Krüger et al, 2012).Vitiligo results in white macules and patches on the body. Initial lesions occur most frequently on the hands, forearms, feet, and face, favoring a periocular or perioral distribution (Ahmed jan N et al., 2023). Vitiligo lesions are classified into 2 major categories: segmental vitiligo (SV) and non-segmental vitiligo (NSV) (Relke et al ., 2019). Segmental vitiligo is characterized by its early onset, rapid stabilization, and unilateral distribution (Van Geel et al., 2017). Non-segmental vitiligo comprises of generalized (vitiligo vulgaris), acrofacial, mucosal (multifocal), and universal vitiligo (Kovacevic et al., 2016). Non-segmental vitiligo (NSV) is the most common form of vitiligo (Benzekri et al., 2013). Multiple mechanisms are involved in melanocyte disappearance, namely genetic predisposition, environmental triggers, metabolic abnormalities, impaired renewal, and altered inflammatory and immune responses (Boniface K et al ., 2018).The results of some studies indicate a frequent association of vitiligo with autoimmune diseases. A number of studies have established a higher prevalence of autoimmune endocrine diseases in women, as well as in non-segmental vitiligo patients and in cases of family history of vitiligo and/or other autoimmune diseases. In addition, it was shown that the prevalence of endocrine diseases increases with increasing area of depigmentation (Troshina EA et al., 2020). Autoimmunity in vitiligo is driven by the IFN-γ-CXCL10 cytokine signaling pathway. Activated melanocyte-specific CD8+ T cells secrete IFN-γ, which signals through the IFN-γ receptor (IFN-γR) to activate JAK1/2 and STAT1. This induces the production of CXCL9 and CXCL10, which signal through their receptor CXCR3 to recruit more auto-reactive T cells to the epidermis, resulting in widespread melanocyte destruction (Harris JE et al., 2017).The lysosomal cysteine proteinases of the papain family are involved in lysosomal bulk proteolysis, major histocompatibility complex class II-mediated antigen presentation, pro-hormone processing, and extracellular matrix remodeling., conditionsModule conditions: Vitiligo, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: blood sample and tissue biopsy, outcomesModule primaryOutcomes measure: Cathepsin L, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 50 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06261060, orgStudyIdInfo id: 2023-0918, secondaryIdInfos id: NCI-2024-01333, type: OTHER, domain: NCI-CTRP Clinical Registry, briefTitle: Low-Dose Sirolimus to Increase Hematopoietic Function in Patients With RUNX1 Familial Platelet Disorder, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-08-31, primaryCompletionDateStruct date: 2026-06-11, completionDateStruct date: 2028-06-11, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: M.D. Anderson Cancer Center, class: OTHER, descriptionModule briefSummary: To learn about the safety and effects of low-dose sirolimus in participants with RUNX1-FPD., conditionsModule conditions: Familial Platelet Disorder, conditions: Hematopoietic, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 6, type: ESTIMATED, armsInterventionsModule interventions name: Sirolimus, outcomesModule primaryOutcomes measure: Safety and adverse events (AEs), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: MD Anderson Cancer Center, city: Houston, state: Texas, zip: 77030, country: United States, contacts name: Courtney DiNardo, MD, role: CONTACT, phone: 713-794-1141, email: cdinardo@mdanderson.org, contacts name: Courtney DiNardo, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, hasResults: False

protocolSection identificationModule nctId: NCT06261047, orgStudyIdInfo id: SDZLEC2023-389-02, briefTitle: Radiotherapy Delays Second-line Drug Therapy for Oligo Progressive Primary Liver Cancer, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2026-01-01, completionDateStruct date: 2026-01-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Shandong Cancer Hospital and Institute, class: OTHER, descriptionModule briefSummary: Recent years have seen significant advancements in the treatment landscape of advanced hepatocellular carcinoma (HCC), with the emergence of targeted and immunotherapy strategies reshaping first-line therapy. Sorafenib, a multi-targeted tyrosine kinase inhibitor, initially set the standard, followed by approvals for lenvatinib, regorafenib, cabozantinib, and ramucirumab. Immunotherapy, particularly combinations like atezolizumab with bevacizumab, has shown superior efficacy over sorafenib. Despite these advances, second-line therapies offer limited progression-free survival (mPFS: 2-3 months), necessitating new approaches. Radiotherapy, bolstered by technological advancements, has shown promise. Techniques like stereotactic body radiotherapy (SBRT) combined with PD-1 inhibitors achieve significant response rates and survival benefits. Combining radiotherapy with targeted immunotherapy has also demonstrated improved outcomes. Radiotherapy, especially in oligometastatic HCC, is increasingly favored due to its ability to enhance local control without increasing toxicity. These developments underscore the evolving landscape of HCC treatment towards personalized and multimodal approaches., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Radiotherapy, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 36, type: ESTIMATED, armsInterventionsModule interventions name: radiotherapy, outcomesModule primaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Overall response rate, secondaryOutcomes measure: Overall survial, secondaryOutcomes measure: Disease control rate, secondaryOutcomes measure: Duration of control, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Jinbo Yue, status: RECRUITING, city: Jinan, state: Shandong, zip: 250000, country: China, contacts name: jinbo yue, role: CONTACT, phone: +86053167626442, email: yuejinbo@hotmail.com, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False

protocolSection identificationModule nctId: NCT06261034, orgStudyIdInfo id: 23-008765, secondaryIdInfos id: 8K12AR084222-15, type: NIH, link: https://reporter.nih.gov/quickSearch/8K12AR084222-15, briefTitle: A Study of Sex Differences in Neurocirculatory Control, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-03, completionDateStruct date: 2027-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-10, sponsorCollaboratorsModule leadSponsor name: Mayo Clinic, class: OTHER, collaborators name: National Institute of Arthritis and Musculoskeletal and Skin Diseases (NIAMS), descriptionModule briefSummary: The purpose of this study is to investigate potential sex differences in neurocirculatory control of blood pressure in patients with untreated obstructive sleep apnea (OSA)., conditionsModule conditions: Obstructive Sleep Apnea, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, outcomesModule primaryOutcomes measure: Blood pressure, primaryOutcomes measure: Arterial stiffness, primaryOutcomes measure: Endothelial function, secondaryOutcomes measure: Sympathetic nerve burst frequency, secondaryOutcomes measure: Sympathetic nerve burst incidence, secondaryOutcomes measure: Sympathetic nerve burst amplitude (AU), secondaryOutcomes measure: Total muscle sympathetic nerve activity (MSNA), otherOutcomes measure: Cerebral autoregulation, otherOutcomes measure: Sympathetic action potentials per burst, otherOutcomes measure: Sympathetic action potential clusters per burst, otherOutcomes measure: Sympathetic action potential conduction latency of each cluster, otherOutcomes measure: Immune function, otherOutcomes measure: Urinary Extracellular Vesicle Presence and Content, otherOutcomes measure: Plasma Extracellular Vesicle Presence and Content, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic in Rochester, city: Rochester, state: Minnesota, zip: 55905, country: United States, contacts name: Joshua Bock, PhD, role: CONTACT, phone: 507-422-0768, email: bock.joshua@mayo.edu, contacts name: Ian Greenlund, PhD, role: CONTACT, phone: (507) 422-3411, email: Greenlund.Ian@mayo.edu, contacts name: Virend Somers, MD, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.02163, lon: -92.4699, hasResults: False

protocolSection identificationModule nctId: NCT06261021, orgStudyIdInfo id: INNO-6051, briefTitle: Study to Evaluate the Efficacy of Ruxolitinib 1.5% Cream in Adult Subjects With Discoid Lupus Erythematosus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-19, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-02, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-25, sponsorCollaboratorsModule leadSponsor name: Innovaderm Research Inc., class: OTHER, descriptionModule briefSummary: This study is a single-blind, intraindividual study to evaluate the efficacy of ruxolitinib 1.5 % cream in adult subjects with discoid lupus erythematosus., conditionsModule conditions: Discoid Lupus Erythematosus, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Intra-individual, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: This study will be single-blinded. Only the efficacy assessor will be blinded in this study (for subjects with randomized areas). The assessor will only assess efficacy and will not have any other interactions with the subject., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Ruxolitinib 1.5% cream, interventions name: Application without occlusion in Area 1, interventions name: Application under occlusion at night in Area 2, interventions name: Application under occlusion at night in Area 1, interventions name: Application without occlusion in Area 2, outcomesModule primaryOutcomes measure: Change from baseline in target lesion CLASI-A score, secondaryOutcomes measure: Change from baseline in target lesion CLASI-A score, secondaryOutcomes measure: Proportion of subjects with an erythema score of 0 (absent), secondaryOutcomes measure: Change from baseline in target lesion SADDLE-A, secondaryOutcomes measure: Proportion of subjects with a target lesion CLA-IGA score of 0 (clear) or 1 (almost clear), otherOutcomes measure: Dermatology Life Quality Index (DLQI), otherOutcomes measure: Cutaneous Lupus Erythematosus Quality of Life (CLEQol), otherOutcomes measure: Numeric Rating Scale(NRS), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Innovaderm Research Inc., status: RECRUITING, city: Montréal, state: Quebec, zip: H2X 2V1, country: Canada, contacts name: Fareheen Chowdhury, MSc, role: CONTACT, phone: 514-521-4285, phoneExt: 341, email: fchowdhury@innovaderm.com, contacts name: Robert Bissonnette, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, hasResults: False

protocolSection identificationModule nctId: NCT06261008, orgStudyIdInfo id: 2023.553, briefTitle: Interactive Telehealth Intervention to Increase Longitudinal Adherence to Repeat Faecal Immunochemical Test Screening, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-15, primaryCompletionDateStruct date: 2025-03-26, completionDateStruct date: 2026-06-26, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Chinese University of Hong Kong, class: OTHER, descriptionModule briefSummary: In Hong Kong, Colorectal cancer ranks second in both cancer incidence and mortality. The government-subsidized population-based CRC screening program (the Program) was launched for asymptomatic individuals aged 50-75 years to undergo biennial FIT screenings. A subsidized follow-up colonoscopy is offered to participants with positive FIT results. Participants are advised to repeat the FIT screening 2 years after receiving a negative result. An automated noninteractive short message service (SMS) text reminder, used by the Program as standard care (SC), is delivered to participants who are due for repeat FIT. According to unpublished data, despite SC, only 34% of participants adhere to biennial repeat FIT in the CRC screening program. Nonadherence to repeat FIT screening is caused by forgetfulness and is associated with an individual's psychological health behaviour., conditionsModule conditions: CRC, Colorectal Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patient will be randomized into either standard care or telehealth intervention group, primaryPurpose: HEALTH_SERVICES_RESEARCH, maskingInfo masking: NONE, maskingDescription: There will no masking, enrollmentInfo count: 370, type: ESTIMATED, armsInterventionsModule interventions name: TI group, outcomesModule primaryOutcomes measure: adherence rate, secondaryOutcomes measure: the number of days to repeat FIT, secondaryOutcomes measure: costs incurred in each study arm, secondaryOutcomes measure: uptake rate in positive FIT, secondaryOutcomes measure: detection rate in positive FIT, secondaryOutcomes measure: qualitative factors associated with repeat FIT adherence, eligibilityModule sex: ALL, minimumAge: 50 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre of Digestive Health, Prince of Wales Hospital, city: Hong Kong, country: Hong Kong, geoPoint lat: 22.27832, lon: 114.17469, hasResults: False

protocolSection identificationModule nctId: NCT06260995, orgStudyIdInfo id: Ref: 230603, briefTitle: The Role of Intermediaries in Connecting Individuals to Local Physical Activity - Study Protocol, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Dublin, Trinity College, class: OTHER, descriptionModule briefSummary: Intermediaries help people to connect to community-based services and supports, including physical activity and exercise groups (physical activities). They do this by acting as a link person. After receiving a referral or self-referral, they conduct an assessment, connect people to services in the community, and follow-up with people over time.This project will investigate if connecting to physical activities through an intermediary can improve health and wellbeing. It will also investigate people's experiences of working with an intermediary. This project is a pilot feasibility study, which means the investigators are evaluating the measures used and the way the trial is designed to see if they are suitable for a larger study in the future., conditionsModule conditions: Physical Inactivity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Social Prescribing Link Worker Intermediary Intervention, interventions name: Local Sports Partnership Community Development Officer Intervention, outcomesModule primaryOutcomes measure: International Physical Activity Questionnaire - Short Form, primaryOutcomes measure: Self-Efficacy for Exercise Scale, primaryOutcomes measure: Short Warwick Edinburgh Mental Well-being Scale, secondaryOutcomes measure: Demographics and Health Status, secondaryOutcomes measure: Semi-structured Interviews - Intervention Participants, secondaryOutcomes measure: Overall Acceptability of the Intervention, secondaryOutcomes measure: Gatekeeper Recruitment Logs, secondaryOutcomes measure: Semi-structured Interviews - Gatekeepers, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Dublin, Trinity College Dublin, status: RECRUITING, city: Dublin 8, zip: D08 W9RT, country: Ireland, contacts name: Megan O'Grady, role: CONTACT, phone: 018963613, email: ogradyme@tcd.ie, geoPoint lat: 53.33306, lon: -6.24889, hasResults: False

protocolSection identificationModule nctId: NCT06260982, orgStudyIdInfo id: 2021PI148, briefTitle: Cognitive Disorders in Hereditary Spastic Paraplegia Type 4, acronym: SPG-TEP, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-01-01, primaryCompletionDateStruct date: 2025-01, completionDateStruct date: 2025-01-02, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: Hereditary spastic paraplegia type 4 is the most frequent mutation of hereditary spastic paraplegias. It is commonly described as pure, with progressive weakness of the lower limbs, pyramidal syndrome and vesico-sphincter disorders. However, cognitive disorders have been reported for over 20 years, but remain poorly characterized., conditionsModule conditions: Spastic Paraplegia, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: 18-FDG-PET, outcomesModule primaryOutcomes measure: cognitive testing, secondaryOutcomes measure: Correlations between neuropsychological tests, clinical examination, PET and general data., secondaryOutcomes measure: Genotype/Phenotype correlations, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centre hospitalier régional universitaire, status: RECRUITING, city: Nancy, zip: 54000, country: France, contacts name: Mathilde Renaud, MD, PhD, role: CONTACT, email: m.renaud2@chru-nancy.fr, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False

protocolSection identificationModule nctId: NCT06260969, orgStudyIdInfo id: TJHH-2023-WM13, briefTitle: Endovascular Treatment of Acute Ischemic Stroke With Underlying Intracranial Artery Stenosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2025-09-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Tianjin Huanhu Hospital, class: OTHER, descriptionModule briefSummary: The study is a prospective multicentre registry study. Patients admitted to 10 stroke centres nationwide from September 2022 to September 2025 with acute ischaemic stroke due to large vessel occlusion considering underlying ICAS and treated with emergency endovascular thrombolysis were included for analysis. Patients who met the general inclusion criteria underwent thrombectomy and the necessary remedial treatment., conditionsModule conditions: Large Vessel Occlusion, conditions: Intracranial Artery Occlusion With Cerebral Infarction, conditions: Endovascular Treatments, conditions: Acute Ischemic Stroke, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 470, type: ESTIMATED, armsInterventionsModule interventions name: balloon dilatation, outcomesModule primaryOutcomes measure: Proportion of patients achieving a clinical prognosis of mRS 0-2 at 90 days, secondaryOutcomes measure: Proportion of patients with a good prognosis early after treatment, secondaryOutcomes measure: Change in final cerebral infarct volume relative to baseline at 24 (-2/+12) hours postoperatively on CT/MR, secondaryOutcomes measure: Vascular recanalization, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Tianjin Huanhu Hospital, status: RECRUITING, city: Tianjin, state: Tianjin, country: China, contacts name: Ming Wei, role: CONTACT, phone: 13502182903, email: drweiming@163.com, geoPoint lat: 39.14222, lon: 117.17667, hasResults: False

protocolSection identificationModule nctId: NCT06260956, orgStudyIdInfo id: U01-ROC-001, secondaryIdInfos id: 1U01AI173032, type: NIH, link: https://reporter.nih.gov/quickSearch/1U01AI173032, briefTitle: Expecting Mother's Study of Consumption or Avoidance of Peanut and Egg, acronym: ESCAPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09, primaryCompletionDateStruct date: 2026-09, completionDateStruct date: 2029-09, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Rochester, class: OTHER, collaborators name: National Institute of Allergy and Infectious Diseases (NIAID), descriptionModule briefSummary: Peanut allergy is the most common cause of fatal and near-fatal food-allergic reactions and egg allergy is among the two most common causes of food-induced anaphylaxis. The proposed research will explore the development of sensitization to these food(s) in infants based on maternal consumption or avoidance during pregnancy and breastfeeding., conditionsModule conditions: Allergy and Immunology, conditions: Peanut and Nut Allergy, conditions: Egg Allergy, conditions: Food Allergy in Infants, conditions: Food Allergy Peanut, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: National, parallel, two arm (one-to-one allocation), single blinded, randomized controlled trial., primaryPurpose: PREVENTION, maskingInfo masking: TRIPLE, maskingDescription: Due to the nature of the intervention, the subjects must know which arm they are assigned to, however, biostatistician and investigators will be blinded to study assignment., whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule interventions name: Avoidance, interventions name: Consumption, outcomesModule primaryOutcomes measure: Egg sensitization, secondaryOutcomes measure: Peanut and egg specific IgG and IgG4, secondaryOutcomes measure: Antibodies in maternal blood, secondaryOutcomes measure: Egg allergy, secondaryOutcomes measure: Antigen concentrations, otherOutcomes measure: Exploratory: Peanut sensitization, otherOutcomes measure: Exploratory: Symptoms, otherOutcomes measure: Exploratory: Peanut sensitization, eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Rochester, city: Rochester, state: New York, zip: 14642, country: United States, geoPoint lat: 43.15478, lon: -77.61556, hasResults: False

protocolSection identificationModule nctId: NCT06260943, orgStudyIdInfo id: 20221220, secondaryIdInfos id: NCI-2024-00566, type: REGISTRY, domain: NCI Clinical Trials Reporting Program (CTRP), briefTitle: Targeted Navigation in Hepatocellular Carcinoma (HCC), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-31, primaryCompletionDateStruct date: 2026-10-31, completionDateStruct date: 2026-10-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Miami, class: OTHER, collaborators name: The V Foundation, descriptionModule briefSummary: The investigators are trying to learn more about the personal perceptions and experiences regarding the needs of patients with liver cancer to help improve the care of all patients. The investigators would like to know whether there are needs that patients have or are aware of, especially those needs that the investigators have not been able to address. The investigators aim to develop a program that helps participants and participant's families to navigate the process of being diagnosed with liver cancer and receiving treatment., conditionsModule conditions: Hepatocellular Carcinoma, conditions: Cholangiocarcinoma, conditions: Hepatobiliary Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 50, type: ESTIMATED, armsInterventionsModule interventions name: Target Navigation Pilot Program, outcomesModule primaryOutcomes measure: Number of Days to First Contact, primaryOutcomes measure: Number of Hours for Each Contact, primaryOutcomes measure: Number of Days to First Appointment, primaryOutcomes measure: Number of Days to First Treatment, primaryOutcomes measure: Number of Months of Total Navigation, primaryOutcomes measure: Number of Participants that Die Within One Year, primaryOutcomes measure: Proportion of Participants Enrolled in Clinical Research, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Miami, city: Miami, state: Florida, zip: 33136, country: United States, contacts name: Gloria Figueroa, role: CONTACT, phone: 305-243-0779, email: gef44@med.miami.edu, contacts name: Patricia Jones, MD, role: CONTACT, phone: (305) 243-0779, email: pdjones@med.miami.edu, contacts name: Patricia Jones, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, hasResults: False

protocolSection identificationModule nctId: NCT06260930, orgStudyIdInfo id: Value of chest ultrasonography, briefTitle: Value of Chest Ultrasonography in ILD Screening, statusModule overallStatus: COMPLETED, startDateStruct date: 2017-01, primaryCompletionDateStruct date: 2019-09, completionDateStruct date: 2019-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Aswan University, class: OTHER, descriptionModule briefSummary: The main aim of this study is to detect the value of transthoracic ultrasonography in the diagnosis and assessment of ILDs in correlation to chest X- ray, blood gases, pulmonary function test and echocardiography and to compare it with high resolution CT (HRCT) as a golden diagnostic investigation., conditionsModule conditions: Interstitial Lung Disease, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ACTUAL, outcomesModule primaryOutcomes measure: Sensitivity and specificity of the lung sonography for interstitial lung disease screening, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06260917, orgStudyIdInfo id: E2-23-4148, briefTitle: The Effect of Urinating Through the Zipper or by Pulling Down the Trousers on Uroflowmetry Parameters in LUTS, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-11-01, primaryCompletionDateStruct date: 2023-12-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Ankara City Hospital Bilkent, class: OTHER, descriptionModule briefSummary: There are many factors that affect uroflowmetry parameters. One of these is the urination position. Research has mostly focused on standing and sitting urination positions. However, those who prefer the standing position as a habit can urinate by opening the zipper or lowering the trousers. Although the effect of these two applications on uroflowmetry parameters in healthy men has been investigated in only one study, their effect on patients with lower urinary tract symptoms has not been examined., conditionsModule conditions: Benign Prostatic Hyperplasia, conditions: Micturition Disorder, conditions: Urinary Obstruction, conditions: Urinary Tract Disease, conditions: Urologic Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ACTUAL, armsInterventionsModule interventions name: position of urination, outcomesModule primaryOutcomes measure: Qmax, primaryOutcomes measure: PVR, primaryOutcomes measure: Qave, primaryOutcomes measure: Duration of voiding, eligibilityModule sex: MALE, minimumAge: 45 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ankara Bilkent City Hospital, city: Ankara, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06260904, orgStudyIdInfo id: AIIMS BBSR/PGThesis/23-24/112, briefTitle: Efficacy and Safety of add-on Apremilast Versus add-on Methotrexate in Patients With Oral Lichen Planus, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2025-01-31, completionDateStruct date: 2025-05-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: All India Institute of Medical Sciences, Bhubaneswar, class: OTHER, descriptionModule briefSummary: Lichen planus is an inflammatory disorder of unknown aetiology affecting the stratified squamous epithelia, with an estimated global prevalence of 0.22 to 0.5 %. Oral mucosa (Oral Lichen Planus; OLP) is the most commonly affected region. Corticosteroids are the primary treatment of choice. A prolonged treatment with steroids is required for clinical improvement, which increases the chances of long-term adverse effects. So, there is a need for newer, effective treatment modalities, such as retinoids, methotrexate, Janus kinase inhibitors, PDE4 inhibitors, etc.Of these, methotrexate is a dihydrofolate reductase inhibitor that inhibits the replication and function of T and B lymphocytes. It has shown a good response to OLP (around 83%) in a study by Lajevardi et al. and can be considered a treatment option in patients with moderate to severe OLP. Apremilast is a drug with a novel immunomodulatory mechanism of action. It inhibits phosphodiesterase type IV, which increases levels of cyclic adenosine monophosphate (cAMP), thus activating protein kinase A and inhibiting various inflammatory mediators. Based on a pilot study by Paul et al., apremilast is associated with clinical improvement in lichen planus.Among the various treatment options, there is a lack of head-on trials. Methotrexate is an immunosuppressant with various systemic adverse effects and requires close monitoring. Whereas apremilast is a non-immunosuppressive drug with a better safety profile, it does not show such adverse effects. These drugs can be used as an add-on to low-dose steroids in view of reducing the adverse effects associated with steroid therapy. To the best of our knowledge, there is no randomized controlled trial comparing these two drugs to date. Hence, the present study has been planned to evaluate the safety and efficacy of methotrexate versus apremilast as an add-on to the standard steroid therapy in OLP patients., conditionsModule conditions: Oral Lichen Planus, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: randomized, add-on, active-controlled, open-label, parallel-design clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 64, type: ESTIMATED, armsInterventionsModule interventions name: Prednisolone, interventions name: Apremilast, interventions name: Methotrexate, outcomesModule primaryOutcomes measure: Pain by Visual Analogue Scale (VAS) score, secondaryOutcomes measure: Severity by Physician global assessment of disease (PGA) score, secondaryOutcomes measure: Severity and pain by oral mucosal disease severity score, secondaryOutcomes measure: serum IL 6 level, secondaryOutcomes measure: Quality of life by using oral health-related quality of life score (ORAL HEALTH IMPACT PROFILE - 14 ), secondaryOutcomes measure: Incidence of treatment-emergent adverse events of both test and control group, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: AIIMS Bhubaneswar, city: Bhubaneswar, state: Odisha, zip: 751019, country: India, contacts name: Monalisa Jena, MD, role: CONTACT, phone: 09438884193, email: pharm_monalisa@aiimsbhubaneswar.edu.in, contacts name: Biswanath Behera, MD, role: CONTACT, phone: 07978351200, email: dermat_biswanath@aiimsbhubaneswar.edu.id, contacts name: Biswanath Behera, role: SUB_INVESTIGATOR, contacts name: Madhusmita Sethy, role: PRINCIPAL_INVESTIGATOR, contacts name: Mowdharani PS, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.27241, lon: 85.83385, hasResults: False

protocolSection identificationModule nctId: NCT06260891, orgStudyIdInfo id: ZnSCD, briefTitle: Zinc Supplementation in Sickle Cell Disease, acronym: ZnSCD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2025-04-01, primaryCompletionDateStruct date: 2026-09-30, completionDateStruct date: 2026-09-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-13, sponsorCollaboratorsModule leadSponsor name: University of California, San Francisco, class: OTHER, collaborators name: American Society Hematology, Research Collaborative, collaborators name: Children's Hospital of Philadelphia, collaborators name: Johns Hopkins University, collaborators name: Baylor College of Medicine, collaborators name: Children's National Research Institute, collaborators name: Children's Hospital Medical Center, Cincinnati, collaborators name: Newark Beth Israel Medical Center, collaborators name: University of Pennsylvania, descriptionModule briefSummary: The goal of this short term prospective Phase II study is to compare the effects of two alternate daily doses of zinc (25 and 40 mg/day) in 34 randomly assigned homozygous Sickle Cell Disease (SCD-SS) patients aged 15-35 years old. The main question it aims to answer is: Which biomarkers are most responsive to zinc supplementation, and what is the maximum tolerated zinc dose that induces the desired changes in biomarkers of bone turnover? Participants will be recruited from 7 American Society Hematology Research Collaborative SCD Centers. Eligible SCD subjects will be invited to participate in the 16-week study, involving 2 baseline blood draws 4 weeks apart, followed by a 12-week zinc intervention. The findings from this study will be used to determine the dosage of zinc to be used in a larger, future study on the long term impact of zinc supplementation on bone health in SCD-SS., conditionsModule conditions: Sickle Cell Disease, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: This is a delayed start parallel design where all subjects will have a usual care period, 2 baseline samples 4 weeks apart, followed by a 12 week zinc intervention, with samples at 8 and 12 weeks., primaryPurpose: OTHER, maskingInfo masking: QUADRUPLE, maskingDescription: n/a the 2 zinc capsule dosages (25 and 40 mg) will be compounded to look identical, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: 25 mg/day zinc, interventions name: 40 mg/day zinc, outcomesModule primaryOutcomes measure: Biomarker of Bone Formation (PINP), primaryOutcomes measure: Biomarker of Bone Resorption (CTx), secondaryOutcomes measure: Biomarker of Bone Formation (BSAP), secondaryOutcomes measure: Biomarker of Bone Resorption (TRAP 5b), eligibilityModule sex: ALL, minimumAge: 15 Years, maximumAge: 35 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: UCSF Benioff Children's Hospital Oakland, city: Oakland, state: California, zip: 94609, country: United States, contacts name: Ellen Fung, PhD, role: CONTACT, phone: 510-428-3885, phoneExt: 4939, email: ellen.fung@ucsf.edu, contacts name: Beth Anne Martin, role: CONTACT, email: beth.martin@ucsf.edu, geoPoint lat: 37.80437, lon: -122.2708, hasResults: False

protocolSection identificationModule nctId: NCT06260878, orgStudyIdInfo id: REB23-0625, briefTitle: Short-term Intravenous Fluids for Prevention of Post-ERCP Pancreatitis, acronym: STRIPE, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-09-01, primaryCompletionDateStruct date: 2027-12-31, completionDateStruct date: 2028-06-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Calgary, class: OTHER, descriptionModule briefSummary: This study will explore the efficacies of several practical short-term (peri-procedural) intravenous fluid regimens in the prevention of post- endoscopic retrograde cholangiopancreatography (ERCP) pancreatitis (PEP). PEP is the most common serious ERCP-related adverse event (AE), occurring in 5-15% of patients, and associated with significant morbidity, mortality, and healthcare utilization. Given the current lack of data on effectiveness of short-term fluid regimens in PEP prevention to inform practice, the results of the proposed study have the strong potential to impact ERCP practices worldwide, whether positive or negative., conditionsModule conditions: Post-ERCP Acute Pancreatitis, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 505, type: ESTIMATED, armsInterventionsModule interventions name: Intravenous Ringer's lactate, outcomesModule primaryOutcomes measure: Serum amylase, secondaryOutcomes measure: Pancreatitis, secondaryOutcomes measure: Bleeding, secondaryOutcomes measure: Cholangitis, secondaryOutcomes measure: Cardiorespiratory adverse event, secondaryOutcomes measure: Serum lipase, secondaryOutcomes measure: Electrolytes, secondaryOutcomes measure: Creatinine, secondaryOutcomes measure: Brain natriuretic peptide, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260865, orgStudyIdInfo id: E-ETH-01K-CI02, briefTitle: A Confirmatory Trial of Multidisciplinary Digital Therapeutics for Patellofemoral Pain Syndrome, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-31, primaryCompletionDateStruct date: 2024-07-31, completionDateStruct date: 2024-08-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: EverEx Inc., class: INDUSTRY, descriptionModule briefSummary: This randomized controlled confirmatory study will be evaluating an mobile application, MORA Cure (ETH-01K), owned by EverEx, Inc., to examine safety and effectiveness in individuals with patellofemoral pain syndrome., conditionsModule conditions: Patellofemoral Pain Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Multicenter randomized controlled trial, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 216, type: ESTIMATED, armsInterventionsModule interventions name: MORA Cure, interventions name: Treatment as Usual, outcomesModule primaryOutcomes measure: Usual pain severity assessed by the Visual Analogue Scale (VAS), secondaryOutcomes measure: Usual pain severity assessed by the Visual Analogue Scale (VAS), secondaryOutcomes measure: Worst pain severity assessed by the Visual Analogue Scale (VAS), secondaryOutcomes measure: Functional disability assessed by the Kujala Patellofemoral Scale, secondaryOutcomes measure: Health-related quality of life assessed by EuroQol five-dimensional (EQ-5D), secondaryOutcomes measure: Assessment of mental health symptoms specific to depression as assessed by the Patient Health Questionnaire-9 (PHQ-9), secondaryOutcomes measure: Assessment of catastrophic thinking measured by Pain Catastrophizing Scale (PCS), secondaryOutcomes measure: Flexion and extension strength of knee, secondaryOutcomes measure: Treatment adherence, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Myongji Hospital, city: Goyang-si, state: Gyeonggi-do, zip: 10475, country: Korea, Republic of, geoPoint lat: 37.65639, lon: 126.835, locations facility: Hanyang University Guri Hospital, city: Guri-si, state: Gyeonggi-do, zip: 11923, country: Korea, Republic of, geoPoint lat: 37.5986, lon: 127.1394, locations facility: CHA Bundang Medical Center, city: Seongnam-si, state: Gyeonggi-do, zip: 13496, country: Korea, Republic of, geoPoint lat: 37.43861, lon: 127.13778, locations facility: Inha University Hospital, city: Junggu, state: Incheon-si, zip: 22332, country: Korea, Republic of, geoPoint lat: 37.69175, lon: 126.60024, locations facility: Chung-Ang University Hospital, city: Dongjak, state: Seoul, zip: 06973, country: Korea, Republic of, geoPoint lat: 35.15713, lon: 126.8166, locations facility: Seoul Metropolitan Government-Seoul National University Boramae Medical Center, city: Dongjak, state: Seoul, zip: 07061, country: Korea, Republic of, geoPoint lat: 35.15713, lon: 126.8166, locations facility: Kyung Hee University Hospital at Gangdong, city: Gangdong, state: Seoul, zip: 05278, country: Korea, Republic of, locations facility: The Catholic University of Korea Seoul St. Mary's Hospital, city: Seocho, state: Seoul, zip: 06591, country: Korea, Republic of, geoPoint lat: 37.49056, lon: 127.02, locations facility: Seoul National University Bundang Hospital, city: Gyeonggi-do, zip: 13620, country: Korea, Republic of, geoPoint lat: 37.58944, lon: 126.76917, locations facility: Asan Medical Center, city: Seoul, zip: 05505, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06260852, orgStudyIdInfo id: ES20/Th8/23-11-2023, briefTitle: Identification of Minimum Focal Points in Vision Curve Formation, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Democritus University of Thrace, class: OTHER, descriptionModule briefSummary: The primary objective of this study is to identify how many focal points and at which distances are necessary for reliable visual curve formation and area of the curve (AoC) calculation using mathematical models and comparing the results to measurements acquired from participants that underwent uncomplicated pseudophakic presbyopia surgery., conditionsModule conditions: Presbyopia, conditions: Pseudophakia, conditions: Cataract, conditions: Refractive Errors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: Diagnostic Test: Visual Acuity Assessment, outcomesModule primaryOutcomes measure: Visual curves interpolation, primaryOutcomes measure: Area of the curve (AOC) assessment, primaryOutcomes measure: Visual acuity assessment, eligibilityModule sex: ALL, minimumAge: 40 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Ophthalmology, University Hospital of Alexandroupolis, status: RECRUITING, city: Alexandroupolis, state: Evros, zip: 68100, country: Greece, contacts name: Georgios Labiris, MD, PhD, role: CONTACT, phone: 00302551030405, email: labiris@usa.net, geoPoint lat: 40.84995, lon: 25.87644, hasResults: False

protocolSection identificationModule nctId: NCT06260839, orgStudyIdInfo id: KY20232442-F-1, briefTitle: the Effect of Minimally Invasive Technique Assisted by Magnetic Resonance Neurography, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-16, primaryCompletionDateStruct date: 2024-12-01, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: He Xiang, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to to compare the therapeutic effect of minimally invasive surgery guided by magnetic resonance neurography(MRN) compared with non-magnetic resonance assisted minimally invasive surgery in patients with moderate to severe gluteal muscle contracture(GMC). The main question it aims to answer are: magnetic resonance neurography can better help optimize the surgical path of minimally invasive surgery in the treatment of gluteal muscle contracture.Participants will underwent preoperative magnetic resonance examination according to different groups, and then the experimental group designed individualized surgical approach and MRN-assisted minimally invasive release according to the imaging findings. In the control group, preoperative magnetic resonance examination was only used to assist in the diagnosis and evaluation of gluteal muscle contracture, and the magnetic resonance results were not used to assist in the design of surgical approach. In the control group, non-MRN-assisted minimally invasive release was performed. The researchers will compare the intraoperative surgery-related indicators and postoperative hip function scores and complications of patients in different groups to see if magnetic resonance-assisted surgery has a better postoperative effect., conditionsModule conditions: Orthopedic Surgery, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: magnetic resonance neurography, interventions name: no magnetic resonance neurography, outcomesModule primaryOutcomes measure: Hip joint outcome score(HOS) scale, primaryOutcomes measure: Objective hip function scoring scale, secondaryOutcomes measure: Hip joint function of patients, secondaryOutcomes measure: Imaging data of patients with gluteal muscle contracture, secondaryOutcomes measure: Record the duration of the patient 's surgery, secondaryOutcomes measure: The record of the length of the surgical incision of the patient, secondaryOutcomes measure: Measurement of intraoperative blood loss, secondaryOutcomes measure: The first ambulation time after operation, secondaryOutcomes measure: postoperative pain score, secondaryOutcomes measure: Postoperative patients were satisfied with the appearance, secondaryOutcomes measure: The record of postoperative wound infection, secondaryOutcomes measure: The occurrence of postoperative wound fat liquefaction, secondaryOutcomes measure: Postoperative wound peripheral nerve vascular injury, secondaryOutcomes measure: Postoperative incision hematoma formation, otherOutcomes measure: Gluteal muscle contracture severity ZHAO 's classification, otherOutcomes measure: Demographic characteristics of patients, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Xijing Hospital, the Fourth Military Medical University, status: RECRUITING, city: Xian, state: Shaanxi, zip: 710032, country: China, contacts name: Xiang He, MS, role: CONTACT, phone: 8684771013, email: caruya@163.com, contacts name: Long Bi, Prof., role: CONTACT, phone: 8684771013, email: bilong@fmmu.edu.cn, contacts name: Long Bi, Prof., role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.25833, lon: 108.92861, hasResults: False

protocolSection identificationModule nctId: NCT06260826, orgStudyIdInfo id: 3977/QĐ-HVQY, briefTitle: CPAP on Oxygenation and Pulmonary Function in Elderly Patients After Major Open Abdominal Surgery, acronym: CPAP, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-12-01, primaryCompletionDateStruct date: 2022-08-20, completionDateStruct date: 2022-08-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Nguyen Dang Thu, class: OTHER, descriptionModule briefSummary: Postoperative continuous positive airway pressure (CPAP) can improve lung function. The risk of pulmonary complications is high after major abdominal surgery but may be reduced by prophylactic postoperative noninvasive ventilation using CPAP. This study compared the effects of auto-CPAP via a nasal mask (JPAP) and constant-CPAP via a facial mask (O2-Max Trio) on oxygenation and pulmonary function in elderly patients after major open abdominal surgery., conditionsModule conditions: Continuous Positive Airway Pressure, conditions: Pulmonary Function, conditions: Older People, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Patients were randomly assigned in a 1:1 ratio to either the O2-Max Trio or JPAP group through a computer-generated randomization list ., primaryPurpose: TREATMENT, maskingInfo masking: NONE, maskingDescription: the treatment allocation was unblinded to both the patient and the staffs, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Auto CPAP via nasal mask (JPAP machine), interventions name: Constant CPAP via facial mask (O2-Max Trio system), outcomesModule primaryOutcomes measure: The oxygenation-PaO2/FiO2, secondaryOutcomes measure: The forced vital capacity (FVC), secondaryOutcomes measure: The forced expiratory volume in the first second-FEV1, secondaryOutcomes measure: The FEV1/FVC ratio, secondaryOutcomes measure: The peak expiratory flow-PEF, eligibilityModule sex: ALL, minimumAge: 60 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: VietXo Friendship Hospital, city: Hanoi, zip: 12108, country: Vietnam, geoPoint lat: 21.0245, lon: 105.84117, hasResults: False

protocolSection identificationModule nctId: NCT06260813, orgStudyIdInfo id: S66277, briefTitle: Biomechanical and Morphological Characterization of PTTD, acronym: PTTD, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-08-22, primaryCompletionDateStruct date: 2028-08-01, completionDateStruct date: 2028-08-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universitaire Ziekenhuizen KU Leuven, class: OTHER, descriptionModule briefSummary: Posterior tibial tendon dysfunction (PTTD) is a progressive condition of the tendon of the tibialis posterior muscle with symptoms of tendinopathy or even rupture. Functionally, it is associated with the inability to lock the mid foot and thus manifests itself as a main contributor to adult acquired flatfoot deformity.Concerning treatment, clinical decision making is currently based on a classification integrating various parameters as pain, flexibility of the foot joints, the condition of the posterior tibial tendon assessed through ultrasound imaging and radiographic assessment of arthritic changes. Surprisingly, this classification does not consider any morphologic characteristics (the shape of a bone or joint) or functional, biomechanical characteristics of the foot and ankle, i.e. based on kinematics (e.g. range of motion) and/or kinetics (center of pressure, angular velocity, moment, power absorption and power generation of a joint).Detailed biomechanical characteristics of the foot and ankle can be reliably collected by instrumented gait analysis wherein a 3D camera system is combined with a force plate and plantar pressure platform. Kinematic studies in the field of PTTD typically considered the foot as a structure consisting of three segments: hind foot, forefoot and hallux. Consequently, the mid foot segment (the Chopart and Lisfranc joints) has been neglected, although it is this segment that is particularly affected in PTTD patients.The aim of this research is to overcome the limitations of the current classification system and treatment of PTTD patients, by complementing the current standard-of-care clinical assessment with better insight in the pathologic changes that occur in PTTD patients., conditionsModule conditions: Posterior Tibial Tendon Dysfunction, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Prospective interventional study that includes PTTD patients (PTTD I, II and III) and a healthy control group., primaryPurpose: DIAGNOSTIC, maskingInfo masking: SINGLE, maskingDescription: PTTD patients (PTTD I, II and III) and a healthy control group., whoMasked: PARTICIPANT, enrollmentInfo count: 100, type: ESTIMATED, armsInterventionsModule interventions name: Radiography, interventions name: Ultrasound, interventions name: MRI, interventions name: CT-scan, interventions name: Gait analysis, outcomesModule primaryOutcomes measure: Kinematic characteristics during Gait analysis, primaryOutcomes measure: Center of pressure during Gait analysis, primaryOutcomes measure: Angular velocity during Gait analysis, primaryOutcomes measure: Moment during Gait analysis, primaryOutcomes measure: Power absorption during Gait analysis, primaryOutcomes measure: Power generation during Gait analysis, primaryOutcomes measure: Bone morphology, secondaryOutcomes measure: American Orthopaedic Foot & Ankle Society (AOFAS) score, secondaryOutcomes measure: European Foot and Ankle Society (EFAS) score, secondaryOutcomes measure: 36-item Short Form Health Survey (SF36), secondaryOutcomes measure: Visual Analogue Scale (VAS) pain, secondaryOutcomes measure: Visual Analogue Scale (VAS) satisfaction, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Leuven, status: RECRUITING, city: Leuven, state: Vlaams-Brabant, zip: 3000, country: Belgium, contacts name: Sander Wuite, role: CONTACT, phone: +32 16 33 83 29, email: sander.wuite@uzleuven.be, contacts name: Kevin Deschamps, role: CONTACT, phone: +32 16 33 88 27, email: kevin.deschamps@uzleuven.be, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06260800, orgStudyIdInfo id: PI 23-3405, briefTitle: Spanish Version of Credibility and Expectancy Questionnaire in Patients With Musculoskeletal Injuries, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-08, primaryCompletionDateStruct date: 2024-07-01, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Valladolid, class: OTHER, descriptionModule briefSummary: Physiotherapy treatment of musculoskeletal injuries should be performed following the main clinical guidelines of person-centered care. Patients' perception of the abilities and facilities provided by physiotherapists boost a convenient therapeutic relationship. This relation is linked with more satisfaction and adherence during the treatment, as well as credibility and expectancy of the patient related to the treatment. Thus, Credibility and Expectancy questionnaire is normally used to assess that point. CEQ presents good psychometric properties when used in Physisiotherapy interventions, but there is not a spanish version of this questionaire., conditionsModule conditions: Validation Study, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Validation CEQ, outcomesModule primaryOutcomes measure: Content validity, primaryOutcomes measure: Construct validity, primaryOutcomes measure: Reliability, primaryOutcomes measure: Criterion validity, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Silvia Lahuerta Martín, status: RECRUITING, city: Soria, zip: 42004, country: Spain, geoPoint lat: 41.76401, lon: -2.46883, hasResults: False

protocolSection identificationModule nctId: NCT06260787, orgStudyIdInfo id: OBGY-202401.01, briefTitle: Clinical Profiles And In Vitro Fertilization Success, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2023-03-31, completionDateStruct date: 2023-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universitas Padjadjaran, class: OTHER, descriptionModule briefSummary: This research was carried out to determine if the IVF patients' clinical profile were connected with how successful in their getting pregnant. This was a cross-sectional study which recruited all patients, performed at a major fertility clinic in Indonesia. Our data collection period spanned between January 2017 and December 2021., conditionsModule conditions: in Vitro Fertilisation, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 223, type: ACTUAL, armsInterventionsModule interventions name: In Vitro Fertilisation, outcomesModule primaryOutcomes measure: Pregnancy rate, eligibilityModule sex: FEMALE, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Obstetrics and Gynecology, Faculty of Medicine, Universitas Padjadjaran, city: Bandung, state: Jawa Barat, zip: 40161, country: Indonesia, geoPoint lat: -6.92222, lon: 107.60694, hasResults: False

protocolSection identificationModule nctId: NCT06260774, orgStudyIdInfo id: TTX-MC138-002, briefTitle: Study of TTX-MC138 in Subjects With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05-30, primaryCompletionDateStruct date: 2026-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: TransCode Therapeutics, class: INDUSTRY, descriptionModule briefSummary: A Phase 1/2 Multicenter, Open-Label, Dose-Escalation and Expansion Study of TTX MC138 in Subjects with Advanced Solid Tumors, conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, phases: PHASE2, designInfo allocation: NON_RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Dose Escalation Study Design, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: TTX-MC138, outcomesModule primaryOutcomes measure: Dose Escalation - Adverse Events, primaryOutcomes measure: Dose Escalation - Overall Response Rate (ORR), eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260761, orgStudyIdInfo id: Dh3108103/64, briefTitle: MIPO Versus Conventional Approach in Volar Locking Plate for Close Fractures Distal End Radius Under WALANT, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-10-05, primaryCompletionDateStruct date: 2023-02-05, completionDateStruct date: 2023-02-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Police General Hospital, Thailand, class: OTHER, descriptionModule briefSummary: The goal of this clinical trial is to compare the Minimally Invasive Plate Osteosynthesis (MIPO) approach with conventional methods in volar locking plate treatment for distal end radius fractures under the Wide Awake Local Anesthesia No Tourniquet (WALANT) technique. The main question it aims to answer is: Does the MIPO approach provide better pain control than the conventional approach of volar locking plate fixation in distal radius fractures under WALANT? Participants will be requested to record their pain on the Visual Analog Scale (VAS), assess their functional scores, and undergo postoperative radiographic evaluations. Researchers will compare the MIPO group and the conventional group to determine the postoperative pain VAS scores, shedding light on the comparative effectiveness of the two approaches., conditionsModule conditions: Radius; Fracture, Lower or Distal End, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: prospective, parallel group, assessor-blinded, randomized controlled trial. randomized with computer generator number and use block-of-four., primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: The data collector, an orthopedic resident unaware of the surgical technique used, obtained information after operation., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 68, type: ACTUAL, armsInterventionsModule interventions name: MIPO, interventions name: Conventional, outcomesModule primaryOutcomes measure: Pain Visual analogue scale, secondaryOutcomes measure: Quick Disabilities of the Arm, Shoulder and Hand, secondaryOutcomes measure: Grip strength, secondaryOutcomes measure: Pinch strength, secondaryOutcomes measure: Range of motion, secondaryOutcomes measure: Aesthetics, secondaryOutcomes measure: Satisfy, secondaryOutcomes measure: Volar tile, secondaryOutcomes measure: ulnar variance, secondaryOutcomes measure: radial inclination, secondaryOutcomes measure: operation time, secondaryOutcomes measure: skin incision, secondaryOutcomes measure: morphine IV use, secondaryOutcomes measure: complication, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Police general hospital, city: Pathum Wan, state: Bangkok, zip: 10330, country: Thailand, geoPoint lat: 13.73649, lon: 100.5239, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2021-10-05, uploadDate: 2024-02-04T06:00, filename: Prot_SAP_000.pdf, size: 1309374, largeDocs typeAbbrev: ICF, hasProtocol: False, hasSap: False, hasIcf: True, label: Informed Consent Form, date: 2021-10-05, uploadDate: 2024-02-04T06:05, filename: ICF_001.pdf, size: 80882, hasResults: False

protocolSection identificationModule nctId: NCT06260748, orgStudyIdInfo id: LBI-CDCA-001, secondaryIdInfos id: 2023-505759-29-00, type: OTHER, domain: EU Clinical Trials Register, briefTitle: A Study of Chenodeoxycholic Acid (CDCA) in Newly Diagnosed Participants With Cerebrotendinous Xanthomatosis (CTX), statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-11-30, completionDateStruct date: 2025-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Leadiant Biosciences, Inc., class: INDUSTRY, descriptionModule briefSummary: This study is designed to demonstrate the beneficial effect of CDCA in the treatment of CTX-associated diarrhea in approximately 10 participants aged 2-75 years old with newly diagnosed CTX or suspected CTX who have never received treatment with CDCA., conditionsModule conditions: Cerebrotendinous Xanthomatoses, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Chenodeoxycholic acid, interventions name: Chenodeoxycholic acid Placebo, outcomesModule primaryOutcomes measure: Change from baseline at Week 4 in average number of stools with a BSS score of 6 or 7 per day, secondaryOutcomes measure: Change in plasma cholestanol levels from baseline to Week 12, secondaryOutcomes measure: Change in urine and/or plasma bile alcohol levels from baseline to Week 12, secondaryOutcomes measure: Incidence of, severity/intensity of, and relationship to study drug of AEs, secondaryOutcomes measure: Incidence of, severity/intensity of, and relationship to study drug of SAEs, secondaryOutcomes measure: Incidence of, severity/intensity of AESIs, secondaryOutcomes measure: Incidence of, severity/intensity of, and changes in laboratory values, secondaryOutcomes measure: Incidence of, severity/intensity of, and changes in physical examination, secondaryOutcomes measure: Incidence of, severity/intensity of, and changes in vital signs, secondaryOutcomes measure: Number of participants with discontinuations due to AEs, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 75 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260735, orgStudyIdInfo id: HS25897 (H2023:073), secondaryIdInfos id: URGP#51472, type: OTHER_GRANT, domain: University of Manitoba, secondaryIdInfos id: RGPIN-2015-05703, type: OTHER_GRANT, domain: NSERC, briefTitle: Non-invasive Spinal Cord Stimulation After Spinal Cord Injury, acronym: SCI-ES-WALK, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-06-15, primaryCompletionDateStruct date: 2024-08-15, completionDateStruct date: 2024-11-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Manitoba, class: OTHER, descriptionModule briefSummary: Spinal cord injury (SCI) is a central nervous system injury that often leads to motor dysfunction. Non-invasive electrical stimulation of the spinal cord has been recognized as a potential method of reactivating lost spinal neural networks to improve motor recovery and exercise response after SCI. Trans-spinal electrical stimulation (ts-ES) has been found to increase functional gains in people after SCI when applied in combination with other motor training protocols.This project aims to evaluate the effects of non-invasive lumbar spinal cord electrical stimulation on the motor function of trunk and lower limbs in people with SCI after augmenting their locomotor training (treadmill stepping) with step-cycle-based electrical peripheral neural stimulation methods., conditionsModule conditions: Spinal Cord Injuries, conditions: Spinal Cord Diseases, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ESTIMATED, armsInterventionsModule interventions name: Trans-spinal electrical stimulation, interventions name: Electrical muscle activation, interventions name: Treadmill walking, outcomesModule primaryOutcomes measure: Neurophysiological markers or stepping, primaryOutcomes measure: Electromyography (EMG) of ankle extensor muscles, primaryOutcomes measure: Metabolic function testing, secondaryOutcomes measure: 6 Min Walk Test, secondaryOutcomes measure: SCIM-Spinal Cord Independence Measure- Mobility scores, secondaryOutcomes measure: Autonomic scores, secondaryOutcomes measure: Rate or Perceived Exertion (RPE) of Submaximal VO2 testing, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 65 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Manitoba, status: RECRUITING, city: Winnipeg, state: Manitoba, zip: R3E 0W2, country: Canada, contacts name: Katinka Stecina, role: CONTACT, phone: 204-789-3761, email: katinka.stecina@umanitoba.ca, geoPoint lat: 49.8844, lon: -97.14704, hasResults: False

protocolSection identificationModule nctId: NCT06260722, orgStudyIdInfo id: 18805, secondaryIdInfos id: J1I-MC-GZBZ, type: OTHER, domain: Eli Lilly and Company, briefTitle: Effect of Retatrutide Compared With Semaglutide in Adult Participants With Type 2 Diabetes and Inadequate Glycemic Control With Metformin With or Without SGLT2 Inhibitor (TRANSCEND-T2D-2), statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-21, primaryCompletionDateStruct date: 2026-12-11, completionDateStruct date: 2027-03-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-17, sponsorCollaboratorsModule leadSponsor name: Eli Lilly and Company, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy and safety of retatrutide compared with semaglutide in participants with Type 2 Diabetes and inadequate glycemic control with metformin with or without sodium-glucose cotransporter-2 inhibitor (SGLT2i). The study will last about 26 months and may include up to 24 visits., conditionsModule conditions: Diabetes Mellitus, Type 2, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 1250, type: ESTIMATED, armsInterventionsModule interventions name: Retatrutide, interventions name: Semaglutide, outcomesModule primaryOutcomes measure: Change from Baseline in Hemoglobin A1c (HbA1c) (%), secondaryOutcomes measure: Change from Baseline in HbA1c (%), secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c < 5.7%, secondaryOutcomes measure: Percent Change from Baseline in Body Weight, secondaryOutcomes measure: Change from Baseline in Body Weight, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 5%, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 10%, secondaryOutcomes measure: Percentage of Participants Who Achieve Weight Reduction of ≥ 15%, secondaryOutcomes measure: Percentage of Participants Who Achieve HbA1c ≤ 6.5% and ≥ 10% Weight Reduction, secondaryOutcomes measure: Percent Change from Baseline in Triglycerides, secondaryOutcomes measure: Percent Change from Baseline in Non- high-density lipoprotein (HDL) Cholesterol, secondaryOutcomes measure: Change from Baseline in Systolic Blood Pressure (SBP), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Alabama - Department of Nutrition Sciences, status: RECRUITING, city: Birmingham, state: Alabama, zip: 35294, country: United States, contacts name: William Garvey, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.52066, lon: -86.80249, locations facility: Neighborhood Healthcare Institute of Health, status: RECRUITING, city: Escondido, state: California, zip: 92025, country: United States, contacts name: James Schultz, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.11921, lon: -117.08642, locations facility: Long Beach Research Institute, status: RECRUITING, city: Long Beach, state: California, zip: 90805, country: United States, contacts name: Ashley Duzik, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.76696, lon: -118.18923, locations facility: Rancho Cucamonga Clinical Research, status: RECRUITING, city: Rancho Cucamonga, state: California, zip: 91730, country: United States, contacts name: Steven Barag, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.1064, lon: -117.59311, locations facility: University of Colorado Anschutz Medical Campus, status: RECRUITING, city: Aurora, state: Colorado, zip: 80045, country: United States, contacts name: Neda Rasouli, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.72943, lon: -104.83192, locations facility: Arrow Clinical Trials, status: RECRUITING, city: Daytona Beach, state: Florida, zip: 32117, country: United States, contacts name: David Billmeier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.21081, lon: -81.02283, locations facility: New Age Medical Research Corporation, status: RECRUITING, city: Miami, state: Florida, zip: 33186, country: United States, contacts name: Janet Gersten, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.77427, lon: -80.19366, locations facility: South Broward Research, status: RECRUITING, city: Miramar, state: Florida, zip: 33027, country: United States, contacts name: Kenneth Blaze, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.98731, lon: -80.23227, locations facility: Clinical Research of Central Florida, status: RECRUITING, city: Winter Haven, state: Florida, zip: 33880, country: United States, contacts name: Eduardo Torres, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.02224, lon: -81.73286, locations facility: Herman Clinical Research, status: RECRUITING, city: Suwanee, state: Georgia, zip: 30024, country: United States, contacts name: Lee Herman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 34.05149, lon: -84.0713, locations facility: Pacific Diabetes & Endocrine Center, status: RECRUITING, city: Honolulu, state: Hawaii, zip: 96813, country: United States, contacts name: ALAN PARSA, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 21.30694, lon: -157.85833, locations facility: Rocky Mountain Clinical Research, status: RECRUITING, city: Idaho Falls, state: Idaho, zip: 83404, country: United States, contacts name: Kevin Prier, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.46658, lon: -112.03414, locations facility: Deaconess Clinic - Gateway Health Center, status: NOT_YET_RECRUITING, city: Newburgh, state: Indiana, zip: 47630, country: United States, contacts name: Renee Galen, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 37.94449, lon: -87.40529, locations facility: IMA Clinical Research Monroe - Armand, status: RECRUITING, city: Monroe, state: Louisiana, zip: 71201, country: United States, contacts name: Clinton Guillory, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.50931, lon: -92.1193, locations facility: MedStar Health Research Institute (MedStar Physician Based Research Network), status: RECRUITING, city: Hyattsville, state: Maryland, zip: 20782, country: United States, contacts name: Jean Park, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 38.95594, lon: -76.94553, locations facility: Brigham and Women's Hospital Diabetes Program, status: RECRUITING, city: Boston, state: Massachusetts, zip: 02115, country: United States, contacts name: Vanita Aroda, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.35843, lon: -71.05977, locations facility: NECCR PrimaCare Research, status: RECRUITING, city: Fall River, state: Massachusetts, zip: 02721, country: United States, contacts name: Ehab Sorial, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.70149, lon: -71.15505, locations facility: Arcturus Healthcare, PLC, Troy Internal Medicine Research Division, status: RECRUITING, city: Troy, state: Michigan, zip: 48098, country: United States, contacts name: Neil Fraser, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.60559, lon: -83.14993, locations facility: Palm Research Center Tenaya, status: RECRUITING, city: Las Vegas, state: Nevada, zip: 89128, country: United States, contacts name: Samer Nakhle, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.17497, lon: -115.13722, locations facility: NYC Research INC, status: RECRUITING, city: Long Island City, state: New York, zip: 11106, country: United States, contacts name: Anastasios Manessis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.74482, lon: -73.94875, locations facility: Medication Management, status: RECRUITING, city: Greensboro, state: North Carolina, zip: 27405, country: United States, contacts name: James Franklin, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.07264, lon: -79.79198, locations facility: Remington Davis Clinical Research, status: RECRUITING, city: Columbus, state: Ohio, zip: 43215, country: United States, contacts name: Elena Christofides, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, locations facility: Intend Research, LLC, status: RECRUITING, city: Norman, state: Oklahoma, zip: 73069, country: United States, contacts name: Lisa Connery, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 35.22257, lon: -97.43948, locations facility: Central States Research, status: RECRUITING, city: Tulsa, state: Oklahoma, zip: 74136, country: United States, contacts name: Sarah Land, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 36.15398, lon: -95.99277, locations facility: The Corvallis Clinic, P.C., status: RECRUITING, city: Corvallis, state: Oregon, zip: 97330, country: United States, contacts name: Brian Curtis, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 44.56457, lon: -123.26204, locations facility: Thomas Jefferson University Hospital, status: NOT_YET_RECRUITING, city: Philadelphia, state: Pennsylvania, zip: 19107, country: United States, contacts name: Serge Jabbour, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.95233, lon: -75.16379, locations facility: Dallas Diabetes Research Center, status: RECRUITING, city: Dallas, state: Texas, zip: 75230, country: United States, contacts name: Julio Rosenstock, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.78306, lon: -96.80667, locations facility: Valley Institute of Research - Fort Worth, status: RECRUITING, city: Fort Worth, state: Texas, zip: 76164, country: United States, contacts name: alex guevara, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.72541, lon: -97.32085, locations facility: Juno Research, status: RECRUITING, city: Houston, state: Texas, zip: 77040, country: United States, contacts name: Damaris Vega, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 29.76328, lon: -95.36327, locations facility: Southern Endocrinology Associates, status: RECRUITING, city: Mesquite, state: Texas, zip: 75149, country: United States, contacts name: Sumana Gangi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 32.7668, lon: -96.59916, locations facility: Texas Valley Clinical Research, status: RECRUITING, city: Weslaco, state: Texas, zip: 78596, country: United States, contacts name: Eduardo Luna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 26.15952, lon: -97.99084, locations facility: Medrasa Clinical Research, status: RECRUITING, city: Wylie, state: Texas, zip: 75098, country: United States, contacts name: Tanvir Ahmad, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 33.01512, lon: -96.53888, locations facility: Central Washington Health Services Association d/b/a Confluence Health, status: RECRUITING, city: Wenatchee, state: Washington, zip: 98801, country: United States, contacts name: Anton Grasch, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 47.42346, lon: -120.31035, locations facility: Exemplar Research, status: RECRUITING, city: Morgantown, state: West Virginia, zip: 26505, country: United States, contacts name: WARD PAINE, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.62953, lon: -79.9559, locations facility: CARE - Centro de Alergia y Enfermedades Respiratorias, status: NOT_YET_RECRUITING, city: Ciudad Autónoma de Buenos Aires, state: Buenos Aires, zip: 1414, country: Argentina, contacts name: Hernan Finkelstein, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Stat Research S.A., status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1023AAB, country: Argentina, contacts name: Lucas Gutnisky, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CIPREC, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1061AAS, country: Argentina, contacts name: Cesar Zaidman, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Médico Viamonte, status: RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1120AAC, country: Argentina, contacts name: Diego Aizenberg, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Mautalen Salud e Investigación, status: NOT_YET_RECRUITING, city: Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1128AAF, country: Argentina, contacts name: José Fretes, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: CEMEDIAB, status: NOT_YET_RECRUITING, city: C.a.b.a., state: Ciudad Autónoma De Buenos Aires, zip: C1205AAO, country: Argentina, contacts name: Alejandro Chertkoff, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Instituto Centenario, status: NOT_YET_RECRUITING, city: Caba, state: Ciudad Autónoma De Buenos Aires, zip: 1204, country: Argentina, contacts name: SUSANA SALZBERG, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Medico Dra. Laura Maffei- Investigacion Clinica Aplicada, status: NOT_YET_RECRUITING, city: Ciudad Autonoma de Buenos Aires, state: Ciudad Autónoma De Buenos Aires, zip: C1425AGC, country: Argentina, contacts name: Antonela Mainardi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Medico Privado San Vicente Diabetes, status: NOT_YET_RECRUITING, city: Cordoba, state: Córdoba, zip: 5006, country: Argentina, contacts name: Cecilia Luquez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: CIPADI - Centro Integral de Prevencion y Atencion en Diabetes, status: RECRUITING, city: Godoy Cruz, state: Mendoza, zip: 5501, country: Argentina, contacts name: Pedro Rosario Fabian Calella, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.92863, lon: -68.8351, locations facility: Centro de Investigaciones Clínicas Baigorria, status: RECRUITING, city: Granadero Baigorria, state: Santa Fe, zip: 2152, country: Argentina, contacts name: Juan Escalante, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.85683, lon: -60.71754, locations facility: Instituto de Investigaciones Clinicas Rosario, status: NOT_YET_RECRUITING, city: Rosario, state: Santa Fe, zip: S2000CVD, country: Argentina, contacts name: Maximiliano Sicer, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -32.94682, lon: -60.63932, locations facility: Fundación Respirar, status: RECRUITING, city: Buenos Aires, zip: C1426ABP, country: Argentina, contacts name: Maria De Salvo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro de Investigaciones Metabólicas (CINME), status: NOT_YET_RECRUITING, city: Ciudad Autónoma de Buenos Aires, zip: C1056ABJ, country: Argentina, contacts name: Federico Perez Manghi, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.61315, lon: -58.37723, locations facility: Centro Diabetológico Dr. Waitman, status: NOT_YET_RECRUITING, city: Córdoba, zip: 5000, country: Argentina, contacts name: JOSE POZZI, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -31.4135, lon: -64.18105, locations facility: University of Calgary - Clinical Trials Unit, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2T 5C7, country: Canada, contacts name: Ronald Sigal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Alberta Diabetes Institute, status: NOT_YET_RECRUITING, city: Edmonton, state: Alberta, zip: T6G 2E1, country: Canada, contacts name: Peter Senior, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 53.55014, lon: -113.46871, locations facility: Aggarwal and Associates Limited, status: RECRUITING, city: Brampton, state: Ontario, zip: L6T 0G1, country: Canada, contacts name: Naresh Aggarwal, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.68341, lon: -79.76633, locations facility: Dr. Steven V. Zizzo Medicine Professional Corporation, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8J 0B6, country: Canada, contacts name: Steven Zizzo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Wharton Medical Clinic, status: NOT_YET_RECRUITING, city: Hamilton, state: Ontario, zip: L8L 5G8, country: Canada, contacts name: Sean Wharton, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Hamilton Medical Research Group, status: RECRUITING, city: Hamilton, state: Ontario, zip: L8M 1K7, country: Canada, contacts name: Richard Tytus, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.25011, lon: -79.84963, locations facility: Bluewater Clinical Research Group Inc., status: NOT_YET_RECRUITING, city: Sarnia, state: Ontario, zip: N7T 4X3, country: Canada, contacts name: John O'Mahony, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 42.97866, lon: -82.40407, locations facility: Prime Health Clinical Research, status: NOT_YET_RECRUITING, city: Toronto, state: Ontario, zip: M4S 1Y2, country: Canada, contacts name: Iris Shasha Gorfinkel, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Maple Leaf Research, status: RECRUITING, city: Toronto, state: Ontario, zip: M5G 1K2, country: Canada, contacts name: Graham Smith, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.70011, lon: -79.4163, locations facility: Private Practice - Dr. Nigel Jagan, status: RECRUITING, city: Whitby, state: Ontario, zip: L1N 2L1, country: Canada, contacts name: Nigel Jagan, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 43.88342, lon: -78.93287, locations facility: 9109-0126 Quebec Inc., status: RECRUITING, city: Montreal, state: Quebec, zip: H4N 2W2, country: Canada, contacts name: Ronald Akhras, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 45.50884, lon: -73.58781, locations facility: RM Pharma Specialists, status: NOT_YET_RECRUITING, city: Mexico City, state: Distrito Federal, zip: 03100, country: Mexico, contacts name: Mariana Crespo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Hospital de Jésus, I.A.P., status: NOT_YET_RECRUITING, city: Mexico City, state: Distrito Federal, zip: 06090, country: Mexico, contacts name: Efrain Villeda Espinosa, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Centro Especializado En Diabetes, Obesidad Y Prevencion De Enfermedades Cardiovasculares, status: NOT_YET_RECRUITING, city: Mexico City, state: Distrito Federal, zip: 11650, country: Mexico, contacts name: Melchor Alpizar Salazar, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.42847, lon: -99.12766, locations facility: Diseno y Planeacion en Investigacion Medica, status: NOT_YET_RECRUITING, city: Guadalajara, state: Jalisco, zip: 44130, country: Mexico, contacts name: Cesar Calvo, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Private Practice - Dr. Arechavaleta Granell Maria del Rosario, status: NOT_YET_RECRUITING, city: Guadalajara, state: Jalisco, zip: 44670, country: Mexico, contacts name: Maria Arechavaleta Granell, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 20.66682, lon: -103.39182, locations facility: Instituto de Diabetes, Obesidad y Nutricion, status: NOT_YET_RECRUITING, city: Cuernavaca, state: Morelos, zip: 62250, country: Mexico, contacts name: Leobardo Sauque Reyna, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.9261, lon: -99.23075, locations facility: Cardiolink Clin Trials, status: NOT_YET_RECRUITING, city: Monterrey, state: Nuevo León, zip: 64060, country: Mexico, contacts name: Elías García, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Clínica García Flores SC, status: NOT_YET_RECRUITING, city: Monterrey, state: Nuevo León, zip: 64610, country: Mexico, contacts name: Pedro Garcia, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 25.67507, lon: -100.31847, locations facility: Enclifar Ensayos Clínicos Farmacológicos Sc, status: NOT_YET_RECRUITING, city: Chihuahua, zip: 31110, country: Mexico, contacts name: Luis Nevarez, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 28.63528, lon: -106.08889, locations facility: Instituto Veracruzano en Investigación Clínica S.C., status: NOT_YET_RECRUITING, city: Veracruz, zip: 91851, country: Mexico, contacts name: Rosa Luna Ceballos, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 19.18095, lon: -96.1429, locations facility: Advanced Clinical Research, LLC, status: RECRUITING, city: Bayamón, zip: 00959, country: Puerto Rico, contacts name: Angel Comulada-Rivera, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.39856, lon: -66.15572, locations facility: GCM Medical Group, PSC - Hato Rey Site, status: RECRUITING, city: San Juan, zip: 00917, country: Puerto Rico, contacts name: Gregorio Cortes-Maisonet, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 18.46633, lon: -66.10572, hasResults: False

protocolSection identificationModule nctId: NCT06260709, orgStudyIdInfo id: NN6019-7565, secondaryIdInfos id: 2022-502605-15-00, type: OTHER, domain: European Medical Agency (EMA), secondaryIdInfos id: U1111-1284-5820, type: OTHER, domain: World Health Organization (WHO), briefTitle: A Research Study to Look at Long-term Treatment With a Medicine Called NNC6019-0001 for People Who Have Heart Failure Due to Transthyretin Amyloidosis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2028-02-29, completionDateStruct date: 2028-02-29, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: This study will test a medicine, NNC6019-0001, for people who have a heart disease due to TTR amyloidosis. It will look at how safe this medicine is in the long term and if it can reduce symptoms of a heart disease due to TTR amyloidosis, such as heart failure. It is an extension to a study called "A research study to look at how a new medicine called NNC6019-0001 works and how safe it is for people who have a heart disease due to TTR amyloidosis". Only participants who have completed that study will be invited for this new study. Participants will get NNC6019-0001, regardless of whether they got placebo or NNC6019-0001 in the first study. The study will last for up to 157 weeks (36 months/3 years)., conditionsModule conditions: Transthyretin Amyloid Cardiomyopathy (ATTR CM), designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule interventions name: NNC6019-0001, outcomesModule primaryOutcomes measure: Number of Treatment Emergent Adverse Events, secondaryOutcomes measure: Change in 6-Minute Walk Test (6MWT), secondaryOutcomes measure: Change in N-terminal-pro brain natriuretic peptide (NT-proBNP), secondaryOutcomes measure: Change in Myocardial Extracellular Volume (ECV), secondaryOutcomes measure: Change in Kansas City Cardiomyopathy Questionnaire (KCCQ) Clinical Summary Score (CSS), secondaryOutcomes measure: Change in Troponin I, secondaryOutcomes measure: Change in Global Longitudinal Strain (GLS) on Echocardiography, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 85 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Mayo Clinic Arizona, status: NOT_YET_RECRUITING, city: Phoenix, state: Arizona, zip: 85054, country: United States, geoPoint lat: 33.44838, lon: -112.07404, locations facility: Cedars-Sinai Medical Center_Los Angeles, status: NOT_YET_RECRUITING, city: Beverly Hills, state: California, zip: 90211, country: United States, geoPoint lat: 34.07362, lon: -118.40036, locations facility: Stanford Hlth Cre-Boswell Clin, status: RECRUITING, city: Stanford, state: California, zip: 94305, country: United States, geoPoint lat: 37.42411, lon: -122.16608, locations facility: Mayo Clinic Jacksonville, status: NOT_YET_RECRUITING, city: Jacksonville, state: Florida, zip: 32224, country: United States, geoPoint lat: 30.33218, lon: -81.65565, locations facility: NW Univ-Bluhm Cardiovasc Inst, status: NOT_YET_RECRUITING, city: Evanston, state: Illinois, zip: 60208, country: United States, geoPoint lat: 42.04114, lon: -87.69006, locations facility: Univ of MD Schl of Med, status: RECRUITING, city: Baltimore, state: Maryland, zip: 21201, country: United States, geoPoint lat: 39.29038, lon: -76.61219, locations facility: Mayo Clinic Rochester, status: NOT_YET_RECRUITING, city: Rochester, state: Minnesota, zip: 55905, country: United States, geoPoint lat: 44.02163, lon: -92.4699, locations facility: University of Calgary_Cardiology, status: NOT_YET_RECRUITING, city: Calgary, state: Alberta, zip: T2N 4Z6, country: Canada, geoPoint lat: 51.05011, lon: -114.08529, locations facility: Ctr for Cardiovascular Innovation, status: NOT_YET_RECRUITING, city: Vancouver, state: British Columbia, zip: V5Z 1M9, country: Canada, geoPoint lat: 49.24966, lon: -123.11934, locations facility: II. interni klinika VFN - Kardiologie a angiologie, status: NOT_YET_RECRUITING, city: Praha 2, zip: 12808, country: Czechia, geoPoint lat: 50.08804, lon: 14.42076, locations facility: Ap-Hp-Hopital Henri Mondor, status: NOT_YET_RECRUITING, city: Créteil, zip: 94000, country: France, geoPoint lat: 48.78333, lon: 2.46667, locations facility: Centre Hospitalier Universitaire de Toulouse-Hopital Rangueil-1, status: NOT_YET_RECRUITING, city: Toulouse Cedex 9, zip: 31059, country: France, geoPoint lat: 43.60426, lon: 1.44367, locations facility: Universitätsklinik Heidelberg Innere Medizin III Kardiologie, Angiologie, Pneumologie, status: NOT_YET_RECRUITING, city: Heidelberg, zip: 69120, country: Germany, geoPoint lat: 49.40768, lon: 8.69079, locations facility: LMU Klinikum München Klinik und Poliklinik 1, status: NOT_YET_RECRUITING, city: München, zip: 81377, country: Germany, geoPoint lat: 48.13743, lon: 11.57549, locations facility: Uniklinik Münster, Klinik für Kardiologie I, status: NOT_YET_RECRUITING, city: Münster, zip: 48149, country: Germany, geoPoint lat: 51.96236, lon: 7.62571, locations facility: Universitatsklinikum Wurzburg AöR, status: NOT_YET_RECRUITING, city: Würzburg, zip: 97078, country: Germany, geoPoint lat: 49.79391, lon: 9.95121, locations facility: Fondazione CNR-Regione Toscana Gabriele Monasterio, status: NOT_YET_RECRUITING, city: Pisa, state: Pi, zip: 56124, country: Italy, geoPoint lat: 43.70853, lon: 10.4036, locations facility: Centro per lo Studio e la Cura delle Amiloidosi Sistemiche Fondazione IRCCS Policlinico San Matteo, status: NOT_YET_RECRUITING, city: Pavia, state: PV, zip: 27100, country: Italy, geoPoint lat: 45.19205, lon: 9.15917, locations facility: UMC Groningen, status: NOT_YET_RECRUITING, city: Groningen, zip: 9713 GZ, country: Netherlands, geoPoint lat: 53.21917, lon: 6.56667, locations facility: Universitair Medisch Centrum Utrecht, status: NOT_YET_RECRUITING, city: Utrecht, zip: 3584 CX, country: Netherlands, geoPoint lat: 52.09083, lon: 5.12222, locations facility: Hospital da Senhora da Oliveira - Guimarães, status: NOT_YET_RECRUITING, city: Guimarães, zip: 4835-044, country: Portugal, geoPoint lat: 41.44443, lon: -8.29619, locations facility: Centro Hospitalar de Trás-os-Montes e Alto Douro, status: NOT_YET_RECRUITING, city: Vila Real, zip: 5000-508, country: Portugal, geoPoint lat: 41.30062, lon: -7.74413, locations facility: Hospital Universitario Puerta de Hierro Majadahonda, status: NOT_YET_RECRUITING, city: Majadahonda, state: Madrid, zip: 28222, country: Spain, geoPoint lat: 40.47353, lon: -3.87182, hasResults: False

protocolSection identificationModule nctId: NCT06260696, orgStudyIdInfo id: DAS-7626, secondaryIdInfos id: U1111-1282-5512, type: OTHER, domain: World Health Organization (WHO), briefTitle: Assessing Health-Related Quality of Life and Willingness to Pay for Weight Management in Asia-Pacific by Gender, acronym: ASPECT - APAC, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-08-10, primaryCompletionDateStruct date: 2023-10-05, completionDateStruct date: 2023-10-05, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Novo Nordisk A/S, class: INDUSTRY, descriptionModule briefSummary: The purpose of this survey is to collect information for scientific research and to identify the impact of overweight and obesity on health-related quality of life., conditionsModule conditions: Overweight, conditions: Obesity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 3000, type: ACTUAL, armsInterventionsModule interventions name: No treatment is given, outcomesModule primaryOutcomes measure: Score on IWQOL-Lite validated, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Novo Nordisk Investigational Site, city: Dubai, country: United Arab Emirates, geoPoint lat: 25.0657, lon: 55.17128, hasResults: False

protocolSection identificationModule nctId: NCT06260683, orgStudyIdInfo id: OSU-22240, secondaryIdInfos id: NCI-2023-04102, type: REGISTRY, domain: CTRP (Clinical Trial Reporting Program), secondaryIdInfos id: R01DA057327, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DA057327, briefTitle: A Comprehensive Evaluation of Tobacco-Flavored vs. Non-Tobacco Flavored E-cigarettes on Smoking Behavior, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-29, primaryCompletionDateStruct date: 2027-04-29, completionDateStruct date: 2027-04-29, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-03, sponsorCollaboratorsModule leadSponsor name: Ohio State University Comprehensive Cancer Center, class: OTHER, collaborators name: National Institute on Drug Abuse (NIDA), descriptionModule briefSummary: This clinical trial compares the use of tobacco flavored electronic cigarettes (ECs) to non-tobacco flavored ECs on smoking behavior in current cigarette smokers to use of nicotine replacement therapy (patches and lozenges). ECs may reduce cigarette craving and withdrawal symptoms, increase motivation and confidence to stop cigarette smoking, and decrease cigarette smoking and dependence. By comparing participants' preferred flavor ECs (PEC) to tobacco flavor ECs (TEC) to NRT, researchers hope to determine the effect of EC flavors on appeal and use, and learn how ECs affect smoking behaviors and health., conditionsModule conditions: Cigarette Smoking-Related Carcinoma, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1500, type: ESTIMATED, armsInterventionsModule interventions name: Nicotine Replacement, interventions name: Questionnaire Administration, interventions name: Vaping, interventions name: Vaping, outcomesModule primaryOutcomes measure: Biochemically verified 7-day point prevalence abstinence from cigarettes, primaryOutcomes measure: Switching rate, secondaryOutcomes measure: Cigarettes smoked per day, secondaryOutcomes measure: Change in nicotine dependence, secondaryOutcomes measure: Changes in cigarette craving and nicotine withdrawal, secondaryOutcomes measure: Number of days used, secondaryOutcomes measure: Product appeal, secondaryOutcomes measure: Continued purchase and use of ECs, eligibilityModule sex: ALL, minimumAge: 21 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ohio State University Comprehensive Cancer Center, city: Columbus, state: Ohio, zip: 43210, country: United States, contacts name: Theodore L. Wagener, PhD, role: CONTACT, email: Theodore.Wagener@osumc.edu, contacts name: Theodore L. Wagener, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.96118, lon: -82.99879, hasResults: False

protocolSection identificationModule nctId: NCT06260670, orgStudyIdInfo id: CP0004, briefTitle: FLOW EVAL-AF: FLOW Mapping Electrogram VALidation in Patients With Persistent Atrial Fibrillation, acronym: FLOW EVAL-AF, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-09-01, primaryCompletionDateStruct date: 2022-10-28, completionDateStruct date: 2022-10-28, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Ablacon, Inc., class: INDUSTRY, descriptionModule briefSummary: FLOW EVAL-AF is a prospective, observational, single center pilot trial. The FLOW EVAL-AF trial is designed to identify driver sources in patients with persistent or longstanding persistent AF using EGF mapping and describe the activation patterns observed from concomitant high density mapping of those regions., conditionsModule conditions: Persistent Atrial Fibrillation, conditions: Longstanding Persistent Atrial Fibrillation, conditions: Atrial Fibrillation, Persistent, conditions: Arrhythmias, Cardiac, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: DIAGNOSTIC, maskingInfo masking: NONE, enrollmentInfo count: 10, type: ACTUAL, armsInterventionsModule interventions name: Electrographic Flow™ Mapping using Ablamap® Software and FIRMap™ Catheter, outcomesModule primaryOutcomes measure: Descriptive correlation of electrogram patterns, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Herz-und Diabeteszentrum NRW (Clinic of Ruhr University of Bochum), city: Bad Oeynhausen, state: North Rhine-Westphalia, zip: 32545, country: Germany, geoPoint lat: 52.20699, lon: 8.80365, hasResults: False

protocolSection identificationModule nctId: NCT06260657, orgStudyIdInfo id: 2021PI124, briefTitle: Search for Olfactory Cells Within the Fetal Ethmoid Epithelium, acronym: COEF, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-10, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Central Hospital, Nancy, France, class: OTHER, descriptionModule briefSummary: The recent rhinological functional approach known as "Evo-Devo" leads us to consider the nose not as a single organ, but as the construction of a specifically olfactory organ within which functional respiratory structures have developed over the course of species evolution in the same way they develop during human embryogenesis.In adult humans, the olfactory structures are limited to two narrow regions situated at the upper part of the nasal passages known as olfactory clefts. Nevertheless, phylogenetic evidence indicates that these olfactory clefts are vestiges of an olfactory organ that once occupied the entire ethmoid bone in the front of the skull base.The hypothesis of this study posits that, during the embryological development of the ethmoid bone, it would initially be covered with olfactory mucosa, which would gradually diminish as the lateral masses of the ethmoid formed, eventually persisting exclusively within the olfactory clefts of the ethmoid by the conclusion of the first trimester (end of organogenesis). Besides their fundamental interest, the results of this study could help understand the still unknown pathogenesis of nasal polyposis, a chronic anosmic disease with a prevalence of 2 to 4% in the French and European population.This study requires a series of ethmoidal samples from human fetuses at various ages between 7 and 15 weeks of gestational age. Specific immunohistological labeling techniques under standard optical microscopy will be used to search for and quantify olfactory nerve cells within the fetal ethmoidal mucosa., conditionsModule conditions: Fetal Ethmoidal Mucosa, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Histological analysis on fetal ethmoids, outcomesModule primaryOutcomes measure: Immunohistological positive signal of primary olfactive neurons, secondaryOutcomes measure: Concentration of primary olfactory neurons immunohistological signals, eligibilityModule sex: ALL, minimumAge: 7 Weeks, maximumAge: 15 Weeks, stdAges: CHILD, contactsLocationsModule locations facility: Centre Hospitalier Régional Universitaire - Service ORL, city: Nancy, country: France, contacts name: Roger Jankowski, MD/PhD, role: CONTACT, email: r.jankowski@chru-nancy.fr, geoPoint lat: 48.68439, lon: 6.18496, hasResults: False

protocolSection identificationModule nctId: NCT06260644, orgStudyIdInfo id: Repairing defective composite, briefTitle: Evaluation of Using Self-adhering Flowable Resin Composite in Repairing Old Defective Resin Composite Restorations Over 18 Months Follow up. (A Randomized Clinical Trial), statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2025-09, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, descriptionModule briefSummary: This research proposal is evaluating the clinical performance of using self-adhering flowable resin composite in repairing old occlusal defective resin composite versus conventional flowable resin composite restoration over 18 months., conditionsModule conditions: Occlusal Caries, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: parallel assignment, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: double ( participants, outcomes assessor) participants and both assessors will be blind to the type of material used, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 34, type: ESTIMATED, armsInterventionsModule interventions name: VertiseTM flowable composite (Kerr,USA), outcomesModule primaryOutcomes measure: Restoration clinical performance using FDI criteria, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 35 Years, stdAges: ADULT, contactsLocationsModule locations facility: Faculty of Dentistry, city: Cairo, zip: 113311, country: Egypt, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06260631, orgStudyIdInfo id: P.T.REC/012/004807, briefTitle: Efficacy of High-intensity Laser Acupuncture in Patients With Chronic, Non-specific Low Back Pain, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-25, primaryCompletionDateStruct date: 2024-08, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Cairo University, class: OTHER, collaborators name: King Khalid University, descriptionModule briefSummary: The purpose of this study is to investigate the efficacy of high-intensity laser acupuncture on peak torque, power of trunk extensors and flexors, back pain, range of motion, function, and satisfaction in patients with chronic nonspecific low back pain (CNLBP)., conditionsModule conditions: Chronic Nonspecific Low-back Pain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: high-intensity laser acupuncture and exercise therapy program, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, maskingDescription: random generator, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: high-intensity laser acupuncture and Exercise therapy program, interventions name: Sham laser acupuncture, outcomesModule primaryOutcomes measure: peak torque, primaryOutcomes measure: peak torque, primaryOutcomes measure: Average Power, primaryOutcomes measure: Average Power, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: Pain Intensity, secondaryOutcomes measure: lumbar flexion and extension ROM assessment, secondaryOutcomes measure: lumbar flexion and extension ROM assessment, secondaryOutcomes measure: Disability, secondaryOutcomes measure: Disability, secondaryOutcomes measure: patient Satisfaction, secondaryOutcomes measure: patient Satisfaction, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Doaa Ayoub Elimy, status: RECRUITING, city: Giza, zip: 11251, country: Egypt, contacts name: Doaa A Elimy, lecturer, role: CONTACT, phone: 00201066474654, email: do3aayoub25@gmail.com, geoPoint lat: 30.00808, lon: 31.21093, hasResults: False

protocolSection identificationModule nctId: NCT06260618, orgStudyIdInfo id: 2021/HRE00065, briefTitle: Effect of Chitodex Gel in Tympanoplasty Surgery, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-11-20, primaryCompletionDateStruct date: 2024-05-13, completionDateStruct date: 2024-05-13, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-20, sponsorCollaboratorsModule leadSponsor name: Central Adelaide Local Health Network Incorporated, class: OTHER_GOV, collaborators name: University of Adelaide, descriptionModule briefSummary: The general purpose of this study is to compare Chitosan-dextran (Chitodex) gel versus current standard of care, Gelfoam, as a middle ear (ME) and external auditory canal (EAC) packing agent as part of tympanoplasty procedures to close tympanic membrane perforations (TMP)., conditionsModule conditions: Tympanic Membrane Perforation, conditions: Tympanic Membrane Inflammation, conditions: Surgery, conditions: Otitis Media, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Single blinded randomised clinical trial, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: Masked: The people receiving the treatment/s, The people analysing the results/data Unmasked: The surgeon administering the treatment., whoMasked: PARTICIPANT, enrollmentInfo count: 44, type: ESTIMATED, armsInterventionsModule interventions name: Gelfoam, interventions name: Chitodex, outcomesModule primaryOutcomes measure: Number of participants with tympanic membrane closure, primaryOutcomes measure: rate of tympanic membrane closure, secondaryOutcomes measure: Number of participants with improved hearing, secondaryOutcomes measure: Number of participants with improved eardrum function, secondaryOutcomes measure: Ease of use of product compared to active comparator - surgeon feedback, secondaryOutcomes measure: Time taken to complete surgery, secondaryOutcomes measure: Number of Participants with improved quality of life, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: The Queen Elizabeth Hospital, status: RECRUITING, city: Adelaide, state: South Australia, zip: 5011, country: Australia, contacts name: Prof Peter John Wormald, MD, role: CONTACT, phone: +61 8 8222 7158, email: pjwormald@gmail.com, contacts name: Emma Barry, BSc (Hons), role: CONTACT, phone: +61 8 8222 7158, email: emma.barry@adelaide.edu.au, contacts name: Prof Peter John Wormald, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: -34.92866, lon: 138.59863, locations facility: The Memorial Hospital, status: RECRUITING, city: North Adelaide, state: South Australia, zip: 5006, country: Australia, contacts name: Prof Peter John Wormald, MD, role: CONTACT, phone: +61 8 8222 7158, email: prwormald@gmail.com, geoPoint lat: -34.90733, lon: 138.59141, hasResults: False

protocolSection identificationModule nctId: NCT06260605, orgStudyIdInfo id: Burcu Bayrak 1, secondaryIdInfos id: Burcu, type: REGISTRY, domain: Bayrak, briefTitle: Complications of Diabetes With Puzzles, acronym: Diabetes with, statusModule overallStatus: COMPLETED, startDateStruct date: 2023-12-19, primaryCompletionDateStruct date: 2024-02-20, completionDateStruct date: 2024-03-04, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-07, sponsorCollaboratorsModule leadSponsor name: Bilecik Seyh Edebali Universitesi, class: OTHER, descriptionModule briefSummary: In this study, it was aimed to investigate the effect of diabetes complications training on endocrine system diseases and nursing care in the Internal Medicine Nursing course on the knowledge level of nursing students., conditionsModule conditions: Diabetes Complications, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 110, type: ACTUAL, armsInterventionsModule interventions name: Education, outcomesModule primaryOutcomes measure: Education, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bilecik Şeyh Edebali University, city: Bilecik, state: Merkez, country: Turkey, geoPoint lat: 40.14192, lon: 29.97932, hasResults: False

protocolSection identificationModule nctId: NCT06260592, orgStudyIdInfo id: Aysun Acun 4, briefTitle: Ethical Attitude and Humanistic Acting Skills of Intensive Care Nurses, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-06, primaryCompletionDateStruct date: 2024-03, completionDateStruct date: 2024-03, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Bilecik Seyh Edebali Universitesi, class: OTHER, descriptionModule briefSummary: Today, rapidly developing technology and changing treatment and care conditions increase the tendency towards ethical values both as an intellectual concept and as a moral guide. The nursing profession, which focuses on people in ethical terms, is also performed by people. This situation brings with it many ethical dilemmas in areas where health care services are provided. In ICUs, long and critical treatments of patients, differences of opinion between the medical team and the institution, non-compliance with patient rights, difficulties in terminal patient care, procedures performed without the patient\&#39;s consent, distribution of limited medical resources, unethical attitudes and attitudes of nurse colleagues, Many issues such as long-term exposure to stressors and constant alarm sounds can cause mental distress and negative emotions in intensive care nurses. One of the effective ways to increase the quality of care provided by nurses is humanistic practice ability. The presence of humanistic practice ability provides more realistic, human-centered nursing care, improves the quality of life of patients, and also positively affects health expenditures., conditionsModule conditions: Humanistic Care Skills, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 400, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Ethical compliance of nurses in the intensive care unit, secondaryOutcomes measure: Humanistic care skills of nurses in the intensive care unit, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bilecik Şeyh Edebali University, status: RECRUITING, city: Bilecik, zip: 11000, country: Turkey, contacts name: Aysun Acun, PhD, role: CONTACT, phone: +905072104506, email: aysun.acun@bilecik.edu.tr, contacts name: Aysun Acun, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 40.14192, lon: 29.97932, hasResults: False

protocolSection identificationModule nctId: NCT06260579, orgStudyIdInfo id: S-number 66153, secondaryIdInfos id: S006722N, type: OTHER_GRANT, domain: Research Foundation Flanders - SBO project, briefTitle: Home-based Exercise and Physical Activity Intervention After Kidney Transplantation: Impact of Exercise Intensity, acronym: PHOENIX-Kidney, statusModule overallStatus: RECRUITING, startDateStruct date: 2022-11-14, primaryCompletionDateStruct date: 2025-09-30, completionDateStruct date: 2029-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: KU Leuven, class: OTHER, collaborators name: University Ghent, descriptionModule briefSummary: This multicentre two-phased RCT aims to evaluate implementation potential, cost-effectiveness, effectiveness, and the role of exercise intensity of a home-based exercise and physical activity intervention to improve de novo kidney transplant recipients' physical fitness, cardiovascular health, gut microbiome characteristics, and health-related quality of life. The first phase of this study comprehends a six-month exercise training intervention. Patients will be randomized into (i) a sham intervention consisting of low-intensity balance and stretching exercises (LIT), (ii) a moderate-intensity aerobic and strength training intervention (MIT), or (iii) a moderate- and high-intensity aerobic and strength training intervention (MHIT). The second phase of this study comprehends a physical activity maintenance intervention provided to MIT and MHIT but not LIT. A total of 147 de novo kidney transplant recipients will be recruited from two independent Belgian transplant centres i.e. UZ Leuven and UZ Ghent., conditionsModule conditions: Physical Activity, conditions: Exercise Training, conditions: Kidney Transplantation, conditions: Physical Fitness, conditions: Cardiovascular Health, conditions: Gut Microbiome, conditions: Health-related Quality of Life, conditions: Implementation, conditions: Cost-effectiveness, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Parallel group randomized controlled trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, maskingDescription: Outcome assessors are blinded to the group allocation of the patients. Due to the nature of the intervention, blinding of the patients is not possible. However, a sham training intervention is provided to the control group., whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 147, type: ESTIMATED, armsInterventionsModule interventions name: Exercise/physical activity, outcomesModule primaryOutcomes measure: Changes in peak oxygen consumption (VO2peak), secondaryOutcomes measure: Health-related physical fitness, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: UZ Ghent, status: RECRUITING, city: Ghent, zip: 9000, country: Belgium, contacts name: Calders Patrick, PhD, role: CONTACT, geoPoint lat: 51.05, lon: 3.71667, locations facility: UZ Leuven, status: RECRUITING, city: Leuven, zip: 3000, country: Belgium, contacts name: Amaryllis Van Craenenbroeck, MD, PhD, role: CONTACT, geoPoint lat: 50.87959, lon: 4.70093, hasResults: False

protocolSection identificationModule nctId: NCT06260566, orgStudyIdInfo id: H-52570, briefTitle: Tolerability of Enteral NAC in Infants, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-05, primaryCompletionDateStruct date: 2027-02, completionDateStruct date: 2027-02, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-15, sponsorCollaboratorsModule leadSponsor name: Sanjiv Harpavat, class: OTHER, collaborators name: Baylor College of Medicine, descriptionModule briefSummary: Biliary atresia (BA) is a neonatal liver disease characterized by impaired bile flow and is the most common indication for pediatric liver transplantation. BA can be treated with the Kasai portoenterostomy (KP), a procedure that attempts to restore bile flow and slow disease progression. However, success of the KP procedure is quite variable, and lack of adjuvant medical therapies following KP is a major gap in pediatric hepatology.This study begins to explore oral N-acetylcysteine (NAC) as a potential medical therapy in BA by determining whether an oral formulation can be given to infants. The primary objective is to determine tolerability of the oral NAC formulation. The primary outcome is tolerating at least 3 out of 4 total doses without emesis. The Bayesian Optimal Interval Design (BOIN) trial design will be used to determine the maximum tolerated dose of oral NAC. Our secondary objective is to assess palatability of the oral NAC formulation by comparing facial expressions when taking oral NAC versus other medications commonly given to cholestatic infants., conditionsModule conditions: Biliary Atresia, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, interventionModelDescription: The study consists of two parts:* Administering applesauce alone (lead-in): In study days 1-2, infants will receive one infant spoon (approximately ½ teaspoon) of plain applesauce by mouth twice a day. If the infant tolerates 3-4 of 4 total doses without emesis, the infant will progress to the final two days of the study.* Administering applesauce plus NAC (for infants who tolerate applesauce in study days 1-2): In study days 3-4, infants will receive an individualized dose of powdered oral NAC mixed into one infant spoon of applesauce by mouth twice a day for a maximum of four doses of NAC medication., primaryPurpose: OTHER, maskingInfo masking: NONE, maskingDescription: N/A. No Masking, enrollmentInfo count: 12, type: ESTIMATED, armsInterventionsModule interventions name: N-Acetylcysteine, outcomesModule primaryOutcomes measure: No emesis within 30 minutes of administration of at least 3 of 4 total doses of oral NAC, secondaryOutcomes measure: Oral NAC palatability compared to clinically indicated medications using the facial expression scale, secondaryOutcomes measure: Oral NAC-specific adverse event evaluation, eligibilityModule sex: ALL, minimumAge: 122 Days, maximumAge: 273 Days, stdAges: CHILD, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260553, orgStudyIdInfo id: SCOG008, briefTitle: Metronomic Oral Vinorelbine Combination With Tislelizumab in EGFR/ALK-negative Advanced NSCLC, statusModule overallStatus: ENROLLING_BY_INVITATION, startDateStruct date: 2024-02-07, primaryCompletionDateStruct date: 2025-02-07, completionDateStruct date: 2025-08-07, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Fujian Cancer Hospital, class: OTHER_GOV, descriptionModule briefSummary: To evaluate the efficacy of metronomic chemotherapy combination with tislelizumab in EGFR/ALK-negative advanced NSCLC patients intolerant to first-line standard chemotherapy., conditionsModule conditions: EGFR/ ALK-negative Advanced NSCLC, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: tislelizumab and metronomic oral vinorelbine, outcomesModule primaryOutcomes measure: PFS, secondaryOutcomes measure: ORR, secondaryOutcomes measure: DCR, secondaryOutcomes measure: AE, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Fujian cancer hospital, city: Fuzhou, state: Fujian, country: China, geoPoint lat: 26.06139, lon: 119.30611, hasResults: False

protocolSection identificationModule nctId: NCT06260540, orgStudyIdInfo id: Core Endurance, briefTitle: Core Endurance in Healthy Young Adults, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-01, primaryCompletionDateStruct date: 2024-02-29, completionDateStruct date: 2024-04-29, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-03-26, sponsorCollaboratorsModule leadSponsor name: Karabuk University, class: OTHER, descriptionModule briefSummary: This study aimed to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time in healthy young adults. The "core" region functions as a connection point between the upper and lower extremities and enables the transfer of force from this region to the extremities. This region is a basic structure where the force required for all movements is generated and transmitted from the proximal segments to the distal segments. "Core" stabilization has a significant impact on limb functionality, and stabilization of the proximal segments is necessary to maintain the mobility and function of the distal segments. To establish a stable base during functional activities, the "core" muscles are activated before the upper and lower extremity muscles. This ensures force production and transfer of resulting forces, thus supporting the mobility of the distal segments. Increasing core stabilization increases force production in the extremities, and control of core strength, balance and movement maximizes upper and lower extremity functions. Any impairment in core stabilization reduces the quality of movement and increases the risk of injury to the upper extremity. Therefore, it has been stated that "core" stabilization has a significant effect on athletic performance and upper extremity functions. There are not enough studies in the literature investigating this effect in healthy young adults. Most existing studies focus on the role of core endurance on athlete performance.The aim of this study is not only to investigate core endurance levels in healthy young adults but also to examine the effect of core endurance levels on upper extremity function, muscle strength and reaction time., conditionsModule conditions: Health Risk Behaviors, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 104, type: ESTIMATED, outcomesModule primaryOutcomes measure: Side bridge test, primaryOutcomes measure: Prone bridge test (plank) test, primaryOutcomes measure: Trunk flexion endurance test, primaryOutcomes measure: Sorensen test, secondaryOutcomes measure: Purdue Pegboard test, secondaryOutcomes measure: Isometric hand dynamometer for muscle strength, secondaryOutcomes measure: Nelson hand reaction test, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 25 Years, stdAges: ADULT, contactsLocationsModule locations facility: Karabuk University, status: RECRUITING, city: Karabuk, zip: 78000, country: Turkey, geoPoint lat: 41.20488, lon: 32.62768, hasResults: False

protocolSection identificationModule nctId: NCT06260527, orgStudyIdInfo id: ARTS-011-101, briefTitle: Safety and Pharmacokinetic Study of ARTS-011 in Chinese Healthy Volunteers, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-08-30, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-09-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Allorion Therapeutics Inc, class: INDUSTRY, descriptionModule briefSummary: This single- and multiple-ascending dose study is a Phase 1, first in human study of ARTS-011. The goal of the study is to assess the safety, tolerability, pharmacokinetics, pharmacodynamics and food effect of ARTS-011 after single and multiple oral doses of ARTS-011 in Chinese healthy volunteers., conditionsModule conditions: Chinese Healthy Volunteer, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: SEQUENTIAL, interventionModelDescription: Single ascending dose (SAD) following by multiple ascending dose (MAD) and food effect study, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 76, type: ESTIMATED, armsInterventionsModule interventions name: ARTS-011, interventions name: Placebo, outcomesModule primaryOutcomes measure: Incidence of Treatment-Emergent Adverse Events (AEs), Serious Adverse Events (SAEs) and Discontinuation Due to AEs, primaryOutcomes measure: Number of Adverse Events (AEs) according to severity, primaryOutcomes measure: Number of participants with change from baseline in vital signs (blood pressure, pulse rate, oral temperature), primaryOutcomes measure: Number of participants with change from baseline in 12-Lead Parameters (PR Interval, QRS Complex, QT Interval, QTC Interval), primaryOutcomes measure: Number of participants with change from baseline physical examination, primaryOutcomes measure: Incidence and magnitude of treatment emergent clinical laboratory abnormalities, primaryOutcomes measure: Number of participants with change in 24-hour creatine clearance from baseline, secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Dose Normalized Maximum Observed Plasma Concentration (Cmax[dn]) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD), secondaryOutcomes measure: Apparent Clearance (CL/F) of ARTS-011 in Single Ascending Dose (SAD) and Multiple Ascending Dose (MAD) if data permit, secondaryOutcomes measure: Area Under the Plasma Concentration-Time Curve From Time Zero Extrapolated to Infinite Time (AUCinf) of ARTS-011 in Single Ascending Dose (SAD), secondaryOutcomes measure: Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau) of ARTS-011 in Multiple Ascending Dose (MAD), secondaryOutcomes measure: Dose Normalized Area Under the Plasma Concentration-Time Profile From Time Zero Extrapolated to Infinite Time (AUCinf[dn]) of ARTS-011 in Single Ascending Dose (SAD), secondaryOutcomes measure: Dose Normalized Area Under the Curve From Time Zero to End of Dosing Interval (AUCtau[dn]) of ARTS-011 in Multiple Ascending Dose (MAD), secondaryOutcomes measure: Maximum Observed Plasma Concentration (Cmax) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Time to Reach Maximum Observed Plasma Concentration (Tmax) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Area under the concentration-time curve from time zero to the time of the last quantifiable concentration (AUC0-last) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Plasma Decay Half-Life (t1/2) of ARTS-011 in Food Effect Cohort, secondaryOutcomes measure: Apparent Clearance (CL/F) of ARTS-011 in Food Effect Cohort if data permit, secondaryOutcomes measure: Apparent Volume of Distribution (Vz/F) of ARTS-011 in Food Effect Cohort if data permit, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 55 Years, stdAges: ADULT, contactsLocationsModule locations facility: Beijing Friendship Hospital, Capital Medical University, status: RECRUITING, city: Beijing, state: Beijing, zip: 100050, country: China, contacts name: Ruihua Dong, MD, role: CONTACT, phone: 010-80839386, email: ruihua_dong_rw@163.com, geoPoint lat: 39.9075, lon: 116.39723, hasResults: False

protocolSection identificationModule nctId: NCT06260514, orgStudyIdInfo id: APR-1051-001, briefTitle: Study of APR-1051 in Patients With Advanced Solid Tumors, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-06, primaryCompletionDateStruct date: 2027-06, completionDateStruct date: 2028-06, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Aprea Therapeutics, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to assess the safety and effectiveness of APR-1051 through the performance of a Phase 1, open-label, safety, PK, and preliminary efficacy study of oral APR-1051 in patients with advanced solid tumors., conditionsModule conditions: Advanced Solid Tumor, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 79, type: ESTIMATED, armsInterventionsModule interventions name: APR-1051, outcomesModule primaryOutcomes measure: Treatment-related adverse events, primaryOutcomes measure: Recommended dose of APR-1051, secondaryOutcomes measure: Pharmacokinetics: Cmax/Cmin of APR-1051, secondaryOutcomes measure: Pharmacokinetics: Tmax of APR-1051, secondaryOutcomes measure: Pharmacokinetics: AUC of APR-1051, secondaryOutcomes measure: Pharmacokinetics: t1/2 of APR-1051, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260501, orgStudyIdInfo id: ATADEK-2023-13/463, briefTitle: Wetting Solution-ideal Body Weight Ratio in Liposuction Procedures, statusModule overallStatus: COMPLETED, startDateStruct date: 2021-09-01, primaryCompletionDateStruct date: 2023-09-30, completionDateStruct date: 2023-10-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Acibadem University, class: OTHER, descriptionModule briefSummary: Although the use of wetting solutions during high-volume liposuction is a standard approach, it is unclear how to optimize wetting solutions and components and their effect on postoperative complications.. Since the super-wet technique (aspiration of 1 cc per 1 cc of infiltrate) was introduced in 1986, it has become one of the most frequently applied techniques worldwide . Adrenaline and lidocaine are often added to WS due to their hemostatic and analgesic effects One of the major advantages of super-wet technique is that blood loss is quite low. However, potential cardiovascular side effects of WS and the amounts of epinephrine and lidocaine they contain, such as volume overload, local anesthetic toxicity, hypertension, arrhythmia, and tachycardia, are still a scoop of investigation. In this study, we examined the WS and the medications it contains from a different perspective to understand the possible cause of these adverse outcomes. Despite the most suitable candidates for liposuction are patients with a BMI\<30 kg/m2 and low comorbidity and age, the patient group undergoing liposuction is often obese, and overweight individuals require that obesity-related pathophysiological changes be taken into consideration. Therefore, we analyzed the patients by dividing them into two groups according to the amount of WS applied according to their IBW (WS/IBW≤90ml/kg: group I and WS/IBW\>90ml/kg: group I). In this study we aimed to evaluate the effect of wetting solutions and components calculated according to ideal body weight (IBW) on postoperative complications, conditionsModule conditions: Liposuction, conditions: Obesity, conditions: Postoperative Complications, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: RETROSPECTIVE, enrollmentInfo count: 192, type: ACTUAL, armsInterventionsModule interventions name: super-wet technique, outcomesModule primaryOutcomes measure: Mean arterial pressure (MAP) was measured to detect hypertension and hypotension., primaryOutcomes measure: The Numerical Pain Rating Scale (NRS) was used to assess postoperative pain level, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Acibadem Altunizade Hospital, city: Istanbul, country: Turkey, geoPoint lat: 41.01384, lon: 28.94966, hasResults: False

protocolSection identificationModule nctId: NCT06260488, orgStudyIdInfo id: 8925, briefTitle: Histological Segmentation of the Superficial Femoral Artery From Microscan to CT Using Artificial Intelligence, acronym: CTPred, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-15, primaryCompletionDateStruct date: 2025-06-15, completionDateStruct date: 2025-08-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University Hospital, Strasbourg, France, class: OTHER, descriptionModule briefSummary: The femoropopliteal artery segment (FPAS) is one of the longest arteries in the human body, undergoing torsion, compression, flexion and extension due to lower limb movements. Endovascular surgery is considered to be the treatment of choice for the peripheral arterial disease, the results of which depend on the physiological forces on the arterial wall, the anatomy of the vessels and the characteristics of the lesions being treated. The atheromatous disease includes, in a simple way, 3 categories of plaques: calcified, fibrous, and lipidic. The study of these plaques and their differentiation in imaging and histology in the FPAS has already been the subject of research. To treat them, there are angioplasty balloons and stents with different designs and components, with different mechanical properties and different impregnated molecules.There is no non-invasive method (imaging) to accurately differentiate lesions along the FPAS. The analysis is performed from the preoperative CT scan, but there are high-resolution scanners that allow a quasi-histological analysis of the tissue.This microscanner can be used ex vivo. In the framework of a project, the learning algorithm was be créated (Convolutional Neural Networks) to automatically segment microscanner slices: after taking FPAS from amputated limbs, we correlated ex-vivo microscanner images of the arteries with their histology. The correlation was then performed manually between the microscanner images, and the histological sections obtained. the algorithm well be trained on these slices and validated its performance. The validation of the CT and microscanner concordance was the subject of scientific publications., conditionsModule conditions: Peripheral Artery Disease, conditions: Femoropopliteal Stenosis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Endovascular surgery, outcomesModule primaryOutcomes measure: Assessing the feasibility of histological segmentation of the superficial femoral artery on preoperative microscanner using artificial intelligence, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06260475, orgStudyIdInfo id: IUA - 246-18, briefTitle: IUA Committee Research Project on the Management of TASC C and D Aortoiliac Lesions, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-08-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universidade do Porto, class: OTHER, collaborators name: Clinical Centre of Serbia, collaborators name: University of Padova, collaborators name: University of Bari, collaborators name: University of Trieste, collaborators name: University of Nis, collaborators name: Centro Hospitalar de Vila Nova de Gaia/Espinho, collaborators name: Hospital Centre Hospitalar de Trás-os-Montes e Alto Douro, collaborators name: Centro Hospitalar do Porto, descriptionModule briefSummary: This study aims to evaluate the clinical, imaging results of endovascular revascularization of the aorto-iliac sector in comparison with aortobifemoral bypass and the hybrid approach, in patients with atherosclerotic disease of the iliac sector classified as type C and D by the TransAtlantic Inter-Society Consensus (TASC II, conditionsModule conditions: Aortoiliac Atherosclerosis, conditions: Aortoiliac Occlusive Disease, conditions: Aortoiliac Atherosclerosis With Gangrene, conditions: Aortoiliac Atherosclerosis Without Gangrene, conditions: Aortoiliac Obstruction, conditions: Peripheral Arterial Disease, conditions: Peripheral Vascular Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: Aortobifemoral bypass, interventions name: aortoiliac stenting, outcomesModule primaryOutcomes measure: Major Amputation, primaryOutcomes measure: Cardiovascular Death, primaryOutcomes measure: acute myorcardial infartion, secondaryOutcomes measure: Major Adverse Limb Events, secondaryOutcomes measure: Major adverse cardiovascular events, secondaryOutcomes measure: Death, otherOutcomes measure: Intensive care unit instay, otherOutcomes measure: acute kidney injury (AKI), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Centro Hospitalar Universitário de São João, EPE, city: Porto, zip: 4200-319, country: Portugal, contacts name: Joao Rocha-Neves, role: CONTACT, phone: +351910486230, email: joaorochaneves@hotmail.com, geoPoint lat: 41.14961, lon: -8.61099, locations facility: Faculdade de Medicina da Universidade do Porto, city: Porto, zip: 4200-319, country: Portugal, geoPoint lat: 41.14961, lon: -8.61099, hasResults: False

protocolSection identificationModule nctId: NCT06260462, orgStudyIdInfo id: 10 years adrenal insufficiency, briefTitle: Effects of Steroid Replacement Therapy on Metabolic, Cardiovascular and Bone Outcomes in Adrenal Insufficiency, statusModule overallStatus: COMPLETED, startDateStruct date: 2012-01-01, primaryCompletionDateStruct date: 2022-09-30, completionDateStruct date: 2023-12-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Palermo, class: OTHER, descriptionModule briefSummary: The current study is a randomized, open study aimed to compare the effects of conventional glucocorticoid replacement treatment and dual-release hydrocortisone on anthropometric, metabolic, cardiovascular and bone outcomes in treatment-naïve patients with primary adrenal insufficiency and secondary adrenal insufficiency in a 10 year-observation period., conditionsModule conditions: Adrenal Insufficiency, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: NONE, enrollmentInfo count: 88, type: ACTUAL, armsInterventionsModule interventions name: dual-release hydrocortisone, interventions name: Conventional glucocortidois, outcomesModule primaryOutcomes measure: Change of body weight, secondaryOutcomes measure: Change of anthropometric parameters, secondaryOutcomes measure: Change of metabolic parameters, secondaryOutcomes measure: Change of insulin sensitivity parameters, secondaryOutcomes measure: Change of cardiovascular parameters, secondaryOutcomes measure: Change of bone metabolic parameters, secondaryOutcomes measure: Change of bone density, secondaryOutcomes measure: Change of vascular parameters, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06260449, orgStudyIdInfo id: Trematode, briefTitle: Different Treatment Approaches of Presumed Trematode-Induced Uveitis, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-10-21, primaryCompletionDateStruct date: 2024-10-21, completionDateStruct date: 2024-12-21, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: Different Treatment Approaches of Presumed Trematode-Induced Uveitis including periocular injection and medical treatment Nd laser treatment, conditionsModule conditions: Uveitis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NON_RANDOMIZED, interventionModel: SINGLE_GROUP, interventionModelDescription: Single group tested by intervention and medical treatment, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 31, type: ESTIMATED, armsInterventionsModule interventions name: Surgical removal, outcomesModule primaryOutcomes measure: Surgical removal, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assiut, city: Assiut, country: Egypt, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False

protocolSection identificationModule nctId: NCT06260436, orgStudyIdInfo id: Tharwat gamal Mohamed, briefTitle: Questionnaire of Lower Urinary Tract Symptoms Among Women Before and After Surgical Correction of Uterine Prolapse, statusModule overallStatus: RECRUITING, startDateStruct date: 2021-05-30, primaryCompletionDateStruct date: 2024-09-30, completionDateStruct date: 2024-12-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Assiut University, class: OTHER, descriptionModule briefSummary: . The study will include patients who underwent Pelvic reconstructive surgery for advanced pelvic organ prolapse (POP-Q ≥ 3). Data regarding preoperative evaluation, surgical procedure, and post-operative management will be collected. women will receive a follow up questionnaire. . The baseline questionnaire included data on age, urinary incontinence, daytime frequency, nocturia, postmicturition dribble, straining, urgency, incomplete bladder emptying, and hesitancy. Women were asked about leakage caused by coughing or sneezing, moving, lifting, sleeping, sexual intercourse, urgency, and rest., conditionsModule conditions: Pelvic Organ Prolapse, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 180, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: effect of surgical correction of pelvic organ prolapse on the lower urinary tract symptoms, secondaryOutcomes measure: effect of surgical correction of pelvic organ prolapse on the quality of life, eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Assuit University, status: RECRUITING, city: Assiut, state: Assuit, zip: 2063045, country: Egypt, contacts name: tharwat gl mohamed, role: CONTACT, phone: 01151166826, email: tharwat.fares3@gmail.com, contacts name: tht tg mohamed, role: CONTACT, phone: 01017941889, email: tharwat.fares3@gmail.com, contacts name: abdelghaffar m mohamed, professor, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 27.18096, lon: 31.18368, hasResults: False

protocolSection identificationModule nctId: NCT06260423, orgStudyIdInfo id: 18/1/2024, briefTitle: The Effect of Clinical Experience on the Quality of Obturation and Periapical Changes of Teeth Treated With Matched Cones in Combination With Bioceramic Sealer, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-02-01, completionDateStruct date: 2025-04-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Al-Azhar University, class: OTHER, descriptionModule briefSummary: Evaluation of the impact of clinical experience on the quality of obturation and periapical changes of clinical cases using lateral compaction with bioceramic sealers and matched cone obturation with bioceramic sealers both clinically and radiographically., conditionsModule conditions: Obturation, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 54, type: ESTIMATED, armsInterventionsModule interventions name: Experienced dentist using lateral compaction with bioceramic sealer., interventions name: Unexperienced dentist using lateral compaction with bioceramic sealer., interventions name: Experienced dentist using Single cone with bioceramic sealer., interventions name: Unexperienced dentist using Single cone with bioceramic sealer., outcomesModule primaryOutcomes measure: Postoperative pain assessment, primaryOutcomes measure: Postoperative pain assessment, primaryOutcomes measure: Postoperative pain assessment, primaryOutcomes measure: Postoperative pain assessment, primaryOutcomes measure: Postoperative pain assessment, secondaryOutcomes measure: The quality of obturation and the voids within the root canal filling, eligibilityModule sex: ALL, minimumAge: 20 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: Al-Azhar university, status: RECRUITING, city: Cairo, zip: 11651, country: Egypt, contacts name: Mohamed Badr, Master, role: CONTACT, phone: 0201111777739, email: badrabueida@gmail.com, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06260410, orgStudyIdInfo id: 10512, secondaryIdInfos id: NL84672.078.23, type: OTHER, domain: CCMO, briefTitle: Data Collection in Lutetium Treated Prostate Cancer: Recording of Progression and Tumor Characteristics, acronym: LUTRAC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-20, primaryCompletionDateStruct date: 2027-02-01, completionDateStruct date: 2027-02-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-22, sponsorCollaboratorsModule leadSponsor name: Erasmus Medical Center, class: OTHER, descriptionModule briefSummary: This prospective study aims to collect data and blood biomarkers from patients undergoing Lu-PSMA therapy at the Erasmus MC. In doing so, it will provide real-world efficacy and safety data on the drug, gather dosimetry data and explore putative biomarkers to identify patients who most benefit from Lu-PSMA treatment., conditionsModule conditions: Prostate Cancer Metastatic, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 150, type: ESTIMATED, armsInterventionsModule interventions name: Blood draw for ctDNA and circulating tumor cell collection., outcomesModule primaryOutcomes measure: Overall survival, secondaryOutcomes measure: Progression free survival, secondaryOutcomes measure: Heterogeneity of PSMA-positivity, secondaryOutcomes measure: Effect of CTC PSMA expression on response to treatment., secondaryOutcomes measure: Effect of biomarkers in blood on response to treatment., secondaryOutcomes measure: PSMA-PET scan data and response to treatment., eligibilityModule sex: MALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Erasmus MC, status: RECRUITING, city: Rotterdam, state: Zuid-Holland, zip: 3015 CN, country: Netherlands, contacts name: Stijn Koolen, PhD, role: CONTACT, phone: +31638740656, email: s.koolen@erasmusmc.nl, geoPoint lat: 51.9225, lon: 4.47917, hasResults: False

protocolSection identificationModule nctId: NCT06260397, orgStudyIdInfo id: analgesia for MRM surgeries, briefTitle: Serratus Anterior Plane Block and Costotransverse Block for Analgesia Following Modified Radical Mastectomy Surgeries, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-28, primaryCompletionDateStruct date: 2025-02-28, completionDateStruct date: 2025-03-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: Adequate pain management following modified radical mastectomy (MRM) is crucial for early ambulation and patient satisfaction. Breast cancer is the most common malignancy in females, with an increasing incidence in recent years. Surgery is one of the mainstays of therapy for breast cancer, and modified radical mastectomy (MRM) is the most effective and common type of invasive surgical treatment. Post-mastectomy pain syndrome (PMPS) is a surgical complication of breast surgery characterized by chronic neuropathic pain. The aim of this study is to investigate the efficacy and safety of single injection CTB versus SAPB on post-operative acute pain as a part of a multimodal analgesia plan in patients undergoing MRM., conditionsModule conditions: Regional Anesthesia Morbidity, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: serratus anterior plane block, interventions name: costotransverse block, interventions name: patient controlled analgesia, outcomesModule primaryOutcomes measure: Visual Analogue Scale score at 0,6,12 and 24 hour post-operatively. visual analogue scale is a scale from 0 to 10, 0 represent no pain at all and 10 represent the worst pain, secondaryOutcomes measure: The total dose of nalbuphine consumption is used postoperatively per patient rescue analgesia for 24., eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260384, orgStudyIdInfo id: FMASU R 139/2022, briefTitle: Wolf-Parkinson-White Syndrome and Asymptomatic Pre-excitation in Africa (a Multicenter WPW African Registry), statusModule overallStatus: RECRUITING, startDateStruct date: 2022-05-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-10-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-26, sponsorCollaboratorsModule leadSponsor name: Ain Shams University, class: OTHER, descriptionModule briefSummary: The purpose of this prospective observational study is to characterize the clinical profile of patients with WPW syndrome and patients with asymptomatic WPW pattern on ECG in different African countries and how these patients are managed across Africa Participants would include many different ethnicities at centers where the number of cardiac patients treated is high. All patients attending outpatient cardiology clinics or referred to Cath Lab for electrophysiological studies who are diagnosed to have a Wolf-Parkinson white pattern on the ECG are either symptomatic or asymptomatic. All patients fulfilling the eligibility criteria will be approached by the research team and asked if they wish to take part in the study.The exclusion criteria will be any participant who does not consent to the study.A baseline cardiovascular history (including hypertension, diabetes, heart failure, coronary artery disease, hyperlipidemia, smoking, valve disease, and arrhythmia) will be recorded.A detailed history will be taken about symptoms, medications and presence of family history of similar cases or sudden cardiac death 12-lead ECG will be recorded to confirm the presence of pre-excitation and determine the localization of the accessory pathway using the modified Aruda algorithm. This will be done by two of the research teams in each center.Then other data from the electrophysiological study and ablation will be filled in by the research team from the data systems of each center., conditionsModule conditions: Wolf Parkinson White Syndrome, conditions: Arrythmias, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 500, type: ESTIMATED, armsInterventionsModule interventions name: electrocardiogram, outcomesModule primaryOutcomes measure: No recurrence of symptoms, primaryOutcomes measure: Assessment of performance outcome of each center, eligibilityModule sex: ALL, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ain shams university, status: RECRUITING, city: Cairo, state: Outside US, zip: 11851, country: Egypt, contacts name: Nabil M Farag, MD, role: CONTACT, phone: +201223102180, email: faragnabil@hotmail.com, contacts role: CONTACT, email: lamallam.eps@gmail.com, contacts name: lamyaa E Allam, MD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 30.06263, lon: 31.24967, hasResults: False

protocolSection identificationModule nctId: NCT06260371, orgStudyIdInfo id: ORIGAMI, briefTitle: National Observatory of Mycoplasma Infections in Children Under 18 Ages in France, acronym: ORIGAMI, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-09-01, primaryCompletionDateStruct date: 2030-09-01, completionDateStruct date: 2030-09-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Association Clinique Thérapeutique Infantile du val de Marne, class: OTHER, collaborators name: GPIP, descriptionModule briefSummary: This study was set up because of an unusual increase in the number of cases of mycoplasma infections in France between June and November 2023.Clinical data from children with mycoplasma infections will be collected to characterise this infection and facilitate hospital management., conditionsModule conditions: Mycoplasma Infections, conditions: Hospitalized Children, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: Number of patients hospitalized for mycoplasma infections, primaryOutcomes measure: medical characterisation of mycoplasma infections, secondaryOutcomes measure: Identify risk factors of serious infection, secondaryOutcomes measure: Identify predictive signs of serious infection, secondaryOutcomes measure: Type of complications, secondaryOutcomes measure: Patients outcome, secondaryOutcomes measure: healthcare used for infected children, secondaryOutcomes measure: treatment used during hospitalisation, secondaryOutcomes measure: clinical description of infected children, secondaryOutcomes measure: Type of mycoplasma involved in infected children, secondaryOutcomes measure: performance of complementary diagnostic tests for lung disorders, secondaryOutcomes measure: compare medical data collected during hospitalisation, eligibilityModule sex: ALL, minimumAge: 1 Day, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: ACTIV, status: RECRUITING, city: Créteil, zip: 94600, country: France, contacts name: Corinne Levy, MD, role: CONTACT, phone: 1 48 85 04 04, phoneExt: +33, email: corinne.levy@activ-france.fr, contacts name: Stéphane Béchet, MSc, role: CONTACT, phone: 1 48 85 04 04, phoneExt: +33, email: stephane.bechet@activ-france.fr, geoPoint lat: 48.78333, lon: 2.46667, hasResults: False

protocolSection identificationModule nctId: NCT06260358, orgStudyIdInfo id: 6043, briefTitle: Multidisciplinary Assesssment of Structured Report for Cervical Cancer Staging, acronym: STRECC, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2025-03-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Fondazione Policlinico Universitario Agostino Gemelli IRCCS, class: OTHER, descriptionModule briefSummary: This study aims to validate a structured report for cervical cancer anchored to the FIGO staging system. A structured report is hypothesized to aid in uniformly applying FIGO staging, reducing staging discrepancies and improving patient care and outcomes.Furthermore, we believe that the participation of the clinicians will improve the quality of the report to minimize the need for multidisciplinary team discussion, conditionsModule conditions: Cervical Cancer, designModule studyType: OBSERVATIONAL, designInfo observationalModel: OTHER, timePerspective: PROSPECTIVE, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Survey, outcomesModule primaryOutcomes measure: Efficacy of a contextual structured report, secondaryOutcomes measure: Difference between satisfaction rate with narrative and structured report;, secondaryOutcomes measure: Comparison Single items response rate (for items 6 to 12 of the questionnaire related to clinical information), on both narrative and structured reports;, secondaryOutcomes measure: Differences in the single 6-to-12 items response rate between structured and narrative reports., eligibilityModule sex: FEMALE, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Advanced Radiology Center, status: RECRUITING, city: Rome, zip: 00168, country: Italy, contacts name: Luca Russo, role: CONTACT, phone: +390630158637, email: luca.russso@unicatt.it, geoPoint lat: 41.89193, lon: 12.51133, hasResults: False

protocolSection identificationModule nctId: NCT06260345, orgStudyIdInfo id: CAPRICE, briefTitle: CommunautAry Pediatric bacteRial Infection in Intensive CarE Unit, acronym: CAPRICE, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-01, primaryCompletionDateStruct date: 2030-01-01, completionDateStruct date: 2030-01-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Association Clinique Thérapeutique Infantile du val de Marne, class: OTHER, collaborators name: GFRUP (Groupe Francophone de Réanimation et d'Urgences Pédiatrique), collaborators name: GPIP : Groupe de Pathologies Infectieuses Pédiatriques, collaborators name: Centre National de Référence des Streptocoques, collaborators name: Centre National de Référence des Pneumocoques, collaborators name: Centre National de Référence des Méningocoques et Haemophilus influenzae, collaborators name: Centre National de Référence des staphylocoques, collaborators name: Centre National de Référence des E. Coli, descriptionModule briefSummary: Severe bacterial infections are a worldwide scourge. However, the epidemiology of this type of infection varies over time. It is therefore essential to monitor them in order to prevent them more effectively. At this time, in France, no monitoring exists for this kind of infections., conditionsModule conditions: Hospitalized Children, conditions: Severe Infection, conditions: Invasive Bacterial Infection, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: PROSPECTIVE, enrollmentInfo count: 3000, type: ESTIMATED, outcomesModule primaryOutcomes measure: number of pediatrics cases of severe communautary bacterial infections, primaryOutcomes measure: medical characterisation of children hospitalized for severe communautary bacterial infection case, secondaryOutcomes measure: Identify risk factors of serious infection, secondaryOutcomes measure: Identify predictive signs of severe cases in infected children., secondaryOutcomes measure: healthcare used for infected children, secondaryOutcomes measure: Type of complications, secondaryOutcomes measure: Patients outcome, secondaryOutcomes measure: treatment used during hospitalisation, secondaryOutcomes measure: Bacterial strain characterization, eligibilityModule sex: ALL, maximumAge: 18 Years, stdAges: CHILD, stdAges: ADULT, contactsLocationsModule locations facility: Association Clinique Thérapeutique Infantile du val de Marne, status: RECRUITING, city: Créteil, zip: 94600, country: France, contacts name: Corinne Levy, MD, role: CONTACT, phone: 1 48 85 04 04, phoneExt: +33, email: corinne.levy@activ-france.fr, contacts name: Stéphane Béchet, MsC, role: CONTACT, phone: 1 48 85 04 04, phoneExt: +33, email: stephane.bechet@activ-france.fr, geoPoint lat: 48.78333, lon: 2.46667, hasResults: False

protocolSection identificationModule nctId: NCT06260332, orgStudyIdInfo id: INST UNM 2302, secondaryIdInfos id: 23-293, type: OTHER, domain: UNM HSC IRB, briefTitle: Physical Activity Intervention for the Improvement of Pain in Young, Hispanic Breast Cancer Survivors, statusModule overallStatus: RECRUITING, startDateStruct date: 2023-10-20, primaryCompletionDateStruct date: 2024-08-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: New Mexico Cancer Care Alliance, class: OTHER, collaborators name: University of New Mexico, descriptionModule briefSummary: This clinical trial tests whether increased activity throughout the day can improve the chronic pain and associated symptoms that breast cancer survivors may experience after surgery. Staying active is a key factor of one's physical, mental, and social health and well-being. Moving more could also reduce pain and associated stress, anxiety, or depression. Using a fitness tracker may help patients to move around more, whether or not they choose to exercise. Information gathered from this study may help researchers learn how the use of a Fitbit tracker with health coaching may improve physical activity and reduce pain in young, Hispanic breast cancer survivors., conditionsModule conditions: Breast Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 25, type: ESTIMATED, armsInterventionsModule interventions name: Supportive Care (Fitbit), outcomesModule primaryOutcomes measure: Recruitment rate (Feasibility), primaryOutcomes measure: Retention rate (Feasibility), primaryOutcomes measure: Adherence rate (Feasibility), primaryOutcomes measure: Incidence of adverse events, secondaryOutcomes measure: Change in chronic post-surgical pain, secondaryOutcomes measure: Change in physical activity, secondaryOutcomes measure: Change in health-related quality of life (hrQOL), eligibilityModule sex: FEMALE, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of New Mexico Comprehensive Cancer Center, status: RECRUITING, city: Albuquerque, state: New Mexico, zip: 87106, country: United States, contacts name: Ellen R Wojcik, MBA-HCM, role: CONTACT, email: ewojcik@salud.unm.edu, contacts name: Cheryl A Sampson, MBA, role: CONTACT, email: ChSampson@salud.unm.edu, contacts name: Jacklyn M Nemunaitis, MD, role: PRINCIPAL_INVESTIGATOR, contacts name: Cindy K Blair, Ph.D., role: SUB_INVESTIGATOR, geoPoint lat: 35.08449, lon: -106.65114, hasResults: False

protocolSection identificationModule nctId: NCT06260319, orgStudyIdInfo id: C19-64, briefTitle: Decoding Developmental Disorders in Humams, acronym: devodecode, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-01-01, primaryCompletionDateStruct date: 2024-01-01, completionDateStruct date: 2024-01-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Institut National de la Santé Et de la Recherche Médicale, France, class: OTHER_GOV, collaborators name: Imagine Institute, collaborators name: Commissariat A L'energie Atomique, descriptionModule briefSummary: The DEVO-DECODE project aims to align our currently limited knowledge currently limited knowledge of the genetic architecture of developmental with our more advanced knowledge of their "phenome".To this end, we aim to establish a homogeneous cohort of patients with with developmental disorders to identify new genetic variants genetic variants, and thus study the association between developmental and genetic variants. Secondary objectives are:2* Carry out WGS studies not only to refine exosomal sequencing data exome sequencing data, but above all to identify and validate non-coding non-coding DNA alterations, in both transcribed and non-transcribed transcribed or non-transcribed genomic domains* Develop precise preclinical models for functional studies of pathophysiological pathways, conditionsModule conditions: Genetic Diseases, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_ONLY, timePerspective: RETROSPECTIVE, enrollmentInfo count: 720, type: ACTUAL, armsInterventionsModule interventions name: Whole genome sequencing and Genome-Epigenome-Phenome Associations, outcomesModule primaryOutcomes measure: Primary objectives, secondaryOutcomes measure: secondary objectives 1, secondaryOutcomes measure: secondary objectives 2, eligibilityModule sex: ALL, minimumAge: 1 Year, maximumAge: 90 Years, stdAges: CHILD, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Institut Imagine, city: Paris, zip: 75015, country: France, geoPoint lat: 48.85341, lon: 2.3488, hasResults: False

protocolSection identificationModule nctId: NCT06260306, orgStudyIdInfo id: STUDY00002568, briefTitle: Hip Activation vs. Hip Activation + Core Stabilization, statusModule overallStatus: COMPLETED, startDateStruct date: 2024-01-24, primaryCompletionDateStruct date: 2024-04-12, completionDateStruct date: 2024-04-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-26, sponsorCollaboratorsModule leadSponsor name: Louisiana State University Health Sciences Center Shreveport, class: OTHER, descriptionModule briefSummary: The purpose of this investigation is to compare the effects of a combined hip activation and core stabilization training home exercise program (HEP) versus a hip activation training HEP alone on lower extremity (LE) frontal plane mechanics in healthy individuals.Specific Aim 1: To determine whether between- and/or within-group differences exist on the Forward Step-Down test (FSDT) when comparing a combined hip activation and core stabilization training HEP as compared to a hip activation training HEP.Specific Aim 2: To determine whether between- and/or within-group differences exist on the peak external knee abduction moment when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.Specific Aim 3: To determine whether between- and/or within-group differences exist on gluteal and core muscle surface electromyography (sEMG) when comparing a combined hip activation and core stabilization training HEP to a hip activation training HEP.Specific Aim 4: To determine whether a dose-response relationship exists between HEP compliance and change on the FSDT, peak external knee abduction moment, and sEMG., conditionsModule conditions: Movement, Abnormal, conditions: Lower Extremity Problem, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, maskingDescription: The PI who will be performing the data analysis will be blinded to participants' random group allocation. The other investigators who will be collecting the outcome data will know the group allocation., whoMasked: INVESTIGATOR, enrollmentInfo count: 34, type: ACTUAL, armsInterventionsModule interventions name: Hip activation home exercise program, interventions name: Hip activation plus core stabilization home exercise program, outcomesModule primaryOutcomes measure: Forward Step Down Test (FSDT), secondaryOutcomes measure: Maximal volitional isometric contraction (MVIC) via sensory electromyography (sEMG) of gluteus maximus (GMax), secondaryOutcomes measure: Mean activation of GMax via sEMG, secondaryOutcomes measure: Peak activation of GMax via sEMG, secondaryOutcomes measure: MVIC via sEMG of gluteus medius (GMed), secondaryOutcomes measure: Mean activation of GMed via sEMG, secondaryOutcomes measure: Peak activation of GMed via sEMG, secondaryOutcomes measure: MVIC via of transversus abdominis (TA), secondaryOutcomes measure: Mean activation of TA via sEMG, secondaryOutcomes measure: Peak activation of TA via sEMG, secondaryOutcomes measure: Peak external knee abduction moment during drop landing task, secondaryOutcomes measure: Compliance with Home Exercise Program, eligibilityModule sex: ALL, minimumAge: 22 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: LSU Health Sciences Center at Shreveport, city: Shreveport, state: Louisiana, zip: 71103, country: United States, geoPoint lat: 32.52515, lon: -93.75018, documentSection largeDocumentModule largeDocs typeAbbrev: Prot_SAP, hasProtocol: True, hasSap: True, hasIcf: False, label: Study Protocol and Statistical Analysis Plan, date: 2023-12-07, uploadDate: 2024-01-18T21:23, filename: Prot_SAP_000.pdf, size: 292995, hasResults: False

protocolSection identificationModule nctId: NCT06260293, orgStudyIdInfo id: 4-2022-0208, briefTitle: The Effect of Post-operative Exercise in Gastric Cancer Patients: A Randomized Controlled Trial (RCT) Study, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-01-03, primaryCompletionDateStruct date: 2024-04-30, completionDateStruct date: 2024-04-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Yonsei University, class: OTHER, descriptionModule briefSummary: Medical advancements are enhancing the survival rates of individuals with gastric cancer. The growing population of gastric cancer survivors underscores the importance of managing treatment-related after-effects and side effects. Diminished physical function in cancer patients, particularly following gastric cancer surgery, is linked to increased mortality. The substantial decline in physical activity post-surgery contributes to a notable reduction in cardiorespiratory fitness and lower extremity muscle strength. Early postoperative exercise has demonstrated positive outcomes in colorectal cancer patients, facilitating early hospital discharge and supporting long-term recovery. However, there is a paucity of research on the efficacy of early postoperative exercise in the context of gastric cancer. Therefore, this study aims to evaluate the impact of early postoperative exercise on physical function following gastric cancer surgery., conditionsModule conditions: Gastric Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: SUPPORTIVE_CARE, maskingInfo masking: NONE, enrollmentInfo count: 52, type: ACTUAL, armsInterventionsModule interventions name: exercise, outcomesModule primaryOutcomes measure: Shorts Physical Performance Battery(SPPB), eligibilityModule sex: ALL, minimumAge: 19 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Department of Surgery, Yonsei University College of Medicine, city: Seoul, country: Korea, Republic of, geoPoint lat: 37.566, lon: 126.9784, hasResults: False

protocolSection identificationModule nctId: NCT06260280, orgStudyIdInfo id: 4, briefTitle: Chronic Sleep Deprivation and Changes in Cortical and Hippocampal Volume, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02-26, primaryCompletionDateStruct date: 2024-05-26, completionDateStruct date: 2024-06-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Instituto Mexicano del Seguro Social, class: OTHER_GOV, descriptionModule briefSummary: Sleep is a physiological state that is essential for human performance, including academic, occupational, interpersonal, and psychological aspects. Sleep disruption or deprivation leads to a loss of psychomotor skills and an increased association with various diseases. Therefore, it is critical to assess how chronic sleep deprivation affects medical residents who work long shifts, including those assigned during their training., conditionsModule conditions: Sleep Deprivation, conditions: Hippocampal Atrophy, conditions: Cortical Irregularity, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: PROSPECTIVE, enrollmentInfo count: 37, type: ESTIMATED, armsInterventionsModule interventions name: Cerebral Nuclear Magnetic Resonance, outcomesModule primaryOutcomes measure: Change in Hippocampal volumetry., primaryOutcomes measure: Change in cortical volumetry, eligibilityModule sex: ALL, minimumAge: 24 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: Unidad Medica de Alta Especialidad No. 1, Bajío, city: Leon, state: Guanajuato, zip: 37260,, country: Mexico, geoPoint lat: 21.12908, lon: -101.67374, hasResults: False

protocolSection identificationModule nctId: NCT06260267, orgStudyIdInfo id: 000417, briefTitle: A Phase 1b Proof-of-concept Trial Exploring the Effects of FE 999322 and FE 999324 in Adults With Mild to Moderate Ulcerative Colitis, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-03-12, primaryCompletionDateStruct date: 2025-09-15, completionDateStruct date: 2025-09-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: Ferring Pharmaceuticals, class: INDUSTRY, descriptionModule briefSummary: To explore the safety of FE 999322 (microbiota suspension) and FE 999324 (microbiota capsule) versus placebo in subjects with active mild to moderate ulcerative colitis (UC)., conditionsModule conditions: Ulcerative Colitis, designModule studyType: INTERVENTIONAL, phases: PHASE1, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 90, type: ESTIMATED, armsInterventionsModule interventions name: Microbiota suspension, interventions name: Microbiota capsule, interventions name: Placebo suspension, interventions name: Placebo capsule, outcomesModule primaryOutcomes measure: Treatment-emergent adverse events from baseline to week 52, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Ferring Investigational Site, status: RECRUITING, city: North Little Rock, state: Arkansas, zip: 72117, country: United States, contacts name: Global Clinical Compliance, role: CONTACT, geoPoint lat: 34.76954, lon: -92.26709, locations facility: Ferring Investigational Site, status: RECRUITING, city: Jacksonville, state: Florida, zip: 32256, country: United States, contacts name: Global Clinical Compliance, role: CONTACT, geoPoint lat: 30.33218, lon: -81.65565, locations facility: Ferring Investigational Site, status: RECRUITING, city: Oklahoma City, state: Oklahoma, zip: 73102, country: United States, contacts name: Global Clinical Compliance, role: CONTACT, geoPoint lat: 35.46756, lon: -97.51643, hasResults: False

protocolSection identificationModule nctId: NCT06260254, orgStudyIdInfo id: 244826201, briefTitle: Effects of Railway Vibration on Sleep and Disease, acronym: BioVib, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: Göteborg University, class: OTHER, collaborators name: University of Pennsylvania, collaborators name: University of Manitoba, descriptionModule briefSummary: This study will investigate the biological mechanisms linking sleep disruption by vibration and noise, and the development of cardiometabolic disease. In a laboratory sleep study, the investigators will play railway vibration of different levels during the night. The investigators will also measure objective sleep quality and quantity, cognitive performance across multiple domains, self-reported sleep and wellbeing outcomes, and blood samples. Blood samples will be analyzed to identify metabolic changes and indicators of diabetes risk in different nights. Identifying biomarkers that are impacted by sleep fragmentation will establish the currently unclear pathways by which railway vibration exposure at night can lead to the development of diseases in the long term, especially metabolic disorders including diabetes., conditionsModule conditions: Noise Exposure, conditions: Sleep Disturbance, conditions: Sleep Hygiene, conditions: Metabolic Disturbance, conditions: Cognitive Change, conditions: Glucose Metabolism Disorders (Including Diabetes Mellitus), conditions: Vibration; Exposure, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, interventionModelDescription: All participants will be exposed to each of the different vibration conditions. Each study night is treated as a separate arm of the crossover study. The order of the vibration exposure conditions will be be randomly assigned across participants using a Latin square design to avoid first-order carryover effects. Each subject will be exposed to one night of each of the following:Quiet night: No noise or vibration will be played, serving as a control night to assess individual baseline sleep, metabolic profile, and cognitive performance; Three railway vibration nights to determine consequences of noise-disrupted sleep. The vibration level in these three nights will be 0.5 mm/s, 0.7 mm/s and 0.9 mm/s respectively, so that exposure-response relationships can be derived., primaryPurpose: BASIC_SCIENCE, maskingInfo masking: DOUBLE, maskingDescription: Participants will be aware that in any given study night they can be exposed to railway vibration and noise. They will not be informed what exposure condition will occur in any given night, but they can become unblinded to the exposure if they are awake, as they will may hear the noise or feel the vibration.Study investigators responsible for analysing cognitive performance variables and physiological sleep data will be be blind to which vibration and noise interventions were introduced on which study nights., whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 24, type: ESTIMATED, armsInterventionsModule interventions name: Railway noise, interventions name: Low level railway vibration, interventions name: Intermediate level railway vibration, interventions name: High level railway vibration, outcomesModule primaryOutcomes measure: Fasting insulin resistance in the morning immediately after the Control night, primaryOutcomes measure: Fasting insulin resistance in the morning immediately after the low vibration night, primaryOutcomes measure: Fasting insulin resistance in the morning immediately after the intermediate vibration night, primaryOutcomes measure: Fasting insulin resistance in the morning immediately after the high vibration night, primaryOutcomes measure: Total sleep time during the Control night, primaryOutcomes measure: Total sleep time during the low vibration night, primaryOutcomes measure: Total sleep time during the intermediate vibration night, primaryOutcomes measure: Total sleep time during the high vibration night, primaryOutcomes measure: Total amount of N1 sleep during the Control night, primaryOutcomes measure: Total amount of N2 sleep during the Control night, primaryOutcomes measure: Total amount of N3 sleep during the Control night, primaryOutcomes measure: Total amount of rapid eye movement (REM) sleep during the Control night, primaryOutcomes measure: Total amount of N1 sleep during the low vibration night, primaryOutcomes measure: Total amount of N2 sleep during the low vibration night, primaryOutcomes measure: Total amount of N3 sleep during the low vibration night, primaryOutcomes measure: Total amount of rapid eye movement (REM) sleep during the low vibration night, primaryOutcomes measure: Total amount of N1 sleep during the intermediate vibration night, primaryOutcomes measure: Total amount of N2 sleep during the intermediate vibration night, primaryOutcomes measure: Total amount of N3 sleep during the intermediate vibration night, primaryOutcomes measure: Total amount of rapid eye movement (REM) sleep during the intermediate vibration night, primaryOutcomes measure: Total amount of N1 sleep during the high vibration night, primaryOutcomes measure: Total amount of N2 sleep during the high vibration night, primaryOutcomes measure: Total amount of N3 sleep during the high vibration night, primaryOutcomes measure: Total amount of rapid eye movement (REM) sleep during the high vibration night, primaryOutcomes measure: Wakefulness after sleep onset (WASO) during the Control night, primaryOutcomes measure: Wakefulness after sleep onset (WASO) during the low vibration night, primaryOutcomes measure: Wakefulness after sleep onset (WASO) during the intermediate night, primaryOutcomes measure: Wakefulness after sleep onset (WASO) during the high vibration night, primaryOutcomes measure: Number of awakenings during the Control night, primaryOutcomes measure: Number of awakenings during exposure to low vibration, primaryOutcomes measure: Number of awakenings during exposure to intermediate vibration, primaryOutcomes measure: Number of awakenings during exposure to high vibration, primaryOutcomes measure: Sleep onset latency (SOL) during the Control Night, primaryOutcomes measure: Sleep onset latency (SOL) during the low vibration night, primaryOutcomes measure: Sleep onset latency (SOL) during the intermediate vibration night, primaryOutcomes measure: Sleep onset latency (SOL) during the high vibration night, primaryOutcomes measure: Sleep efficiency during the Control night, primaryOutcomes measure: Sleep efficiency during the low vibration night, primaryOutcomes measure: Sleep efficiency during the intermediate vibration night, primaryOutcomes measure: S Sleep efficiency during the high vibration night, primaryOutcomes measure: Sleep depth assessed using the odds ratio product (ORP) during the Control night, primaryOutcomes measure: Sleep depth assessed using the odds ratio product (ORP) during the low vibration night, primaryOutcomes measure: Sleep depth assessed using the odds ratio product (ORP) during the intermediate vibration night, primaryOutcomes measure: Sleep depth assessed using the odds ratio product (ORP) during the high vibration night, primaryOutcomes measure: Maximal change of odds ratio product (ORP) during exposure to railway vibration events, primaryOutcomes measure: Area under the curve of odds ratio product (ORP) during exposure to railway vibration events, calculated using the trapezoid rule, primaryOutcomes measure: N-acetylglucosamine/galactosamine (GlycA) concentration after the Control night, primaryOutcomes measure: N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to low vibration night, primaryOutcomes measure: N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to intermediate vibration, primaryOutcomes measure: N-acetylglucosamine/galactosamine (GlycA) concentration after exposure to high vibration, primaryOutcomes measure: Sialic acid (GlycB) concentration after the Control night, primaryOutcomes measure: Sialic acid (GlycB) concentration after exposure to low vibration, primaryOutcomes measure: Sialic acid (GlycB) concentration after exposure to intermediate vibration, primaryOutcomes measure: Sialic acid (GlycB) concentration after exposure to high vibration, primaryOutcomes measure: Supramolecular phospholipid composite (SPC) concentration after the Control night, primaryOutcomes measure: Supramolecular phospholipid composite (SPC) concentration after exposure to low vibration, primaryOutcomes measure: Supramolecular phospholipid composite (SPC) concentration after exposure to intermediate vibration, primaryOutcomes measure: Supramolecular phospholipid composite (SPC) concentration after exposure to high vibration, primaryOutcomes measure: Ethanol concentration (mmol/L) after the Control night, primaryOutcomes measure: Ethanol concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Ethanol concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Ethanol concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Trimethylamine-N-oxide concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: 2-Aminobutyric acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Alanine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Alanine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Alanine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Alanine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Asparagine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Asparagine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Asparagine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Asparagine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Creatine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Creatine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Creatine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Creatine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Creatinine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Creatinine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Creatinine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Creatinine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Glutamic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Glutamic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Glutamic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Glutamic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Glutamine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Glutamine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Glutamine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Glutamine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Glycine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Glycine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Glycine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Glycine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Histidine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Histidine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Histidine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Histidine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Isoleucine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Isoleucine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Isoleucine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Isoleucine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Leucine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Leucine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Leucine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Leucine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Lysine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Lysine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Lysine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Lysine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Methionine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Methionine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Methionine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Methionine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: N,N-Dimethylglycine concentration (mmol/L) after Control night, primaryOutcomes measure: N,N-Dimethylglycine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: N,N-Dimethylglycine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: N,N-Dimethylglycine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Ornithine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Ornithine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Ornithine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Ornithine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Phenylalanine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Phenylalanine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Phenylalanine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Phenylalanine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Proline concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Proline concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Proline concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Proline concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Sarcosine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Sarcosine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Sarcosine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Sarcosine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Threonine concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Threonine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Threonine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Threonine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Tyrosine concentration (mmol/L) after exposure toControl night, primaryOutcomes measure: Tyrosine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Tyrosine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Tyrosine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Valine concentration (mmol/L) after Control night, primaryOutcomes measure: Valine concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Valine concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Valine concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: 2-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Acetic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Acetic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Acetic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Acetic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Citric acid concentration (mmol/L) after Control night, primaryOutcomes measure: Citric acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Citric acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Citric acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Formic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Formic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Formic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Formic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Lactic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Lactic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Lactic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Lactic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Succinic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Succinic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Succinic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Succinic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Choline concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Choline concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Choline concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Choline concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: 2-Oxoglutaric acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: 3-Hydroxybutyric acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Acetoacetic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Acetoacetic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Acetoacetic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Acetoacetic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Acetone concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Acetone concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Acetone concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Acetone concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Pyruvic acid concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Pyruvic acid concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Pyruvic acid concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Pyruvic acid concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: D-Galactose concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: D-Galactose concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: D-Galactose concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: D-Galactose concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Glucose concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Glucose concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Glucose concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Glucose concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Glycerol concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Glycerol concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Glycerol concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Glycerol concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Dimethylsulfone concentration (mmol/L) after exposure to Control night, primaryOutcomes measure: Dimethylsulfone concentration (mmol/L) after exposure to low vibration night, primaryOutcomes measure: Dimethylsulfone concentration (mmol/L) after exposure to intermediate vibration night, primaryOutcomes measure: Dimethylsulfone concentration (mmol/L) after exposure to high vibration night, primaryOutcomes measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the control night, primaryOutcomes measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the low vibration night, primaryOutcomes measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the intermediate vibration night, primaryOutcomes measure: Response to an oral glucose bolus, calculated as area under curve for glucose, in the morning after the high vibration night, primaryOutcomes measure: Response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night, primaryOutcomes measure: Response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night, primaryOutcomes measure: Response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night, primaryOutcomes measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the control night, primaryOutcomes measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the low vibration night, primaryOutcomes measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the intermediate vibration night, primaryOutcomes measure: Early response to an oral glucose load calculated as area under curve for insulin, in the morning after the high vibration night, primaryOutcomes measure: Glucose tolerance in the morning after exposure to low vibration, assessed as glucose concentration 120 minutes after a glucose bolus, primaryOutcomes measure: Glucose tolerance in the morning after exposure to intermediate vibration, assessed as glucose concentration 120 minutes after a glucose bolus, primaryOutcomes measure: Glucose tolerance in the morning after exposure to high vibration, assessed as glucose concentration 120 minutes after a glucose bolus, primaryOutcomes measure: Glucose tolerance in the morning after Control night, assessed as glucose concentration 120 minutes after a glucose bolus, primaryOutcomes measure: Stumvoll Insulin sensitivity Index in the morning after control, primaryOutcomes measure: Stumvoll Insulin sensitivity Index in the morning after exposure to low vibration, primaryOutcomes measure: Stumvoll Insulin sensitivity Index in the morning after exposure to intermediate vibration, primaryOutcomes measure: Stumvoll Insulin sensitivity Index in the morning after exposure to high vibration, primaryOutcomes measure: Matsuda insulin sensitivity index in the morning after control exposure, primaryOutcomes measure: Matsuda insulin sensitivity index in the morning after exposure to low vibration, primaryOutcomes measure: Matsuda insulin sensitivity index in the morning after exposure to intermediate vibration, primaryOutcomes measure: Matsuda insulin sensitivity index in the morning after exposure to high vibration, secondaryOutcomes measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control, secondaryOutcomes measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration, secondaryOutcomes measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration, secondaryOutcomes measure: Evening subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration, secondaryOutcomes measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to control, secondaryOutcomes measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to low vibration, secondaryOutcomes measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to intermediate vibration, secondaryOutcomes measure: Morning subjective sleepiness, assessed using the Karolinska Sleepiness Scale after exposure to high vibration, secondaryOutcomes measure: Self-reported sleep disturbance by vibration after control exposure, secondaryOutcomes measure: Self-reported sleep disturbance by vibration after exposure to low vibration, secondaryOutcomes measure: Self-reported sleep disturbance by vibration after exposure to intermediate vibration, secondaryOutcomes measure: Self-reported sleep disturbance by vibration after exposure to high vibration, secondaryOutcomes measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure, secondaryOutcomes measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration, secondaryOutcomes measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration, secondaryOutcomes measure: Morning positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration, secondaryOutcomes measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after control exposure, secondaryOutcomes measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration, secondaryOutcomes measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration, secondaryOutcomes measure: Morning negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration, secondaryOutcomes measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control, secondaryOutcomes measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration, secondaryOutcomes measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration, secondaryOutcomes measure: Evening negative affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration, secondaryOutcomes measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to control, secondaryOutcomes measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to low vibration, secondaryOutcomes measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to intermediate vibration, secondaryOutcomes measure: Evening positive affect, assessed using the Positive and Negative Affect Schedule (PANAS) after exposure to high vibration, secondaryOutcomes measure: Event-related cardiovascular activation in response to control, secondaryOutcomes measure: Event-related cardiovascular activation in response to low vibration, secondaryOutcomes measure: Event-related cardiovascular activation in response to intermediate vibration, secondaryOutcomes measure: Event-related cardiovascular activation in response to high vibration, secondaryOutcomes measure: Evening neurobehavioural speed, secondaryOutcomes measure: Evening neurobehavioural accuracy, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 30 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Gothenburg, status: RECRUITING, city: Gothenburg, state: Västra Götaland, zip: 42650, country: Sweden, contacts name: Michael G Smith, PhD, role: CONTACT, phone: +46317862843, email: michael.smith@amm.gu.se, geoPoint lat: 57.70716, lon: 11.96679, hasResults: False

protocolSection identificationModule nctId: NCT06260241, orgStudyIdInfo id: ShaikhZayedH, briefTitle: Gain in Stretched Penile Length After Phalloplasty With & Without Penile Traction in Children., statusModule overallStatus: RECRUITING, startDateStruct date: 2023-01-01, primaryCompletionDateStruct date: 2025-01-01, completionDateStruct date: 2025-01-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Shaikh Zayed Hospital, Lahore, class: OTHER, descriptionModule briefSummary: The goal of this Randomized Controlled Trial is to assess the gain in stretched penile length after phalloplasty with \& without penile traction in children of age group 4 to 13 years presenting in hospital with the complaint of concealed penis.The main question\[s\] it aims to answer is:• Gain in stretched penile length after phalloplasty with and without penile traction in children., conditionsModule conditions: Concealed Penis, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Randomized Control Trial, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 70, type: ESTIMATED, armsInterventionsModule interventions name: Traction Dressing, interventions name: Without Traction Dressing, outcomesModule primaryOutcomes measure: The gain in stretched penile length (SPL), eligibilityModule sex: MALE, minimumAge: 4 Years, maximumAge: 13 Years, stdAges: CHILD, contactsLocationsModule locations facility: Sheikh Zayed Hospital, status: RECRUITING, city: Lahore, state: Punjab, country: Pakistan, contacts name: ADEEL AHMED, MBBS MS, role: CONTACT, phone: 00923491467739, email: numberdar12@gmail.com, geoPoint lat: 31.558, lon: 74.35071, hasResults: False

protocolSection identificationModule nctId: NCT06260228, orgStudyIdInfo id: STUDY02002270, briefTitle: HOme-Based Self-management and COgnitive Training CHanges Lives (HOBSCOTCH)-Parkinson's Disease (HOBSCOTCH-Parkinson's), acronym: HOBSCOTCH-PD, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-05, primaryCompletionDateStruct date: 2024-08-01, completionDateStruct date: 2024-11-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Dartmouth-Hitchcock Medical Center, class: OTHER, descriptionModule briefSummary: The goal of this pilot study is to assess the feasibility of adapting and delivering the existing home-based epilepsy self-management intervention, HOBSCOTCH, for people with Parkinson's Disease (PD)The main questions it aims to answer are:1. Can the current HOBSCOTCH program be adapted for people with PD?2. Will people with PD experience improved quality of life similar to that found in people with epilepsy after participating in the HOBSCOTCH program?Participants will be asked to:* attend nine, one-hour virtual (online and/or by telephone) HOBSCOTCH-PD sessions with a one-on-one certified HOBSCOTCH-PD coach* complete a brief clinical questionnaire about their diagnosis of PD* complete two questionnaires before and after the HOBSCOTCH-PD sessions about their quality of life and about memory and thinking processes* keep a short daily diary about their PD symptoms and use of the self-management strategies taught in the HOBSCOTCH-PD program* complete a brief Satisfaction Survey after the entire HOBSCOTCH-PD program, conditionsModule conditions: Parkinson Disease, conditions: Cognitive Dysfunction, conditions: Memory Disorders, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: NA, interventionModel: SINGLE_GROUP, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 5, type: ESTIMATED, armsInterventionsModule interventions name: HOme-Based Self-management and COgnitive Training CHanges lives (HOBSCOTCH), outcomesModule primaryOutcomes measure: Change in quality of life as measured by comparing PDQ-39 (Parkinson's Disease Questionnaire) scores pre- and post-HOBSCOTCH-PD intervention., primaryOutcomes measure: Change in subjective cognition as measured by comparing Neuro-QOL Item Bank v2.0 Cognitive Function scores pre- and post-HOBSCOTCH-PD intervention., eligibilityModule sex: ALL, minimumAge: 30 Years, maximumAge: 75 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Dartmouth-Hitchcock, status: RECRUITING, city: Lebanon, state: New Hampshire, zip: 03756, country: United States, contacts name: Sarah J Kaden, role: CONTACT, phone: 603-540-5824, email: sarah.j.kaden@hitchcock.org, geoPoint lat: 43.64229, lon: -72.25176, hasResults: False

protocolSection identificationModule nctId: NCT06260215, orgStudyIdInfo id: FFH, briefTitle: Recovery Kinetics Following a Soccer Training in Middle-aged Males, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02-05, primaryCompletionDateStruct date: 2024-02-26, completionDateStruct date: 2024-03-09, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-21, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: This study aims at investigating the recovery kinetics of skeletal muscle damage, neuromuscular fatigue and performance following a single soccer trainning session in middle aged males. The participants will perform a soccer training session \[A single training session including 60 minutes of warm up, soccer technical exercises and small-sided game\] and a cotrol trial (No intervention included, only daily measurements) in randomized, repeated measures, crossover design. Assesesments related to skeletal muscle damage, performance and neuromuscular fatigue will be executed before the training session and daily for four consecutive days after training., conditionsModule conditions: Skeletal Muscle Damage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: OTHER, maskingInfo masking: NONE, enrollmentInfo count: 11, type: ESTIMATED, armsInterventionsModule interventions name: ST, outcomesModule primaryOutcomes measure: Change in White blood cell count, primaryOutcomes measure: Change in Granulocyte cell count, primaryOutcomes measure: Change in Platelets cell count, primaryOutcomes measure: Change in Monocyte cell count, primaryOutcomes measure: Change in Lymphocyte cell count, primaryOutcomes measure: Change in percentage of Hematocrit level, primaryOutcomes measure: Change Red blood cells count, primaryOutcomes measure: Change in Hemoglobin level, primaryOutcomes measure: Change in Creatine kinase activity, primaryOutcomes measure: Change in Total antioxidant capacity, primaryOutcomes measure: Change in Glutathione concentration in blood, primaryOutcomes measure: Change in countermovement jump height, primaryOutcomes measure: Change in Peak power during coutermovement jump test, primaryOutcomes measure: Change in isometric peak torque of knee extensors and flexors, primaryOutcomes measure: Change in sprint time of 10 m, primaryOutcomes measure: Change in sprint time of 30 m, primaryOutcomes measure: Change in delayed onset of muscle soreness, secondaryOutcomes measure: Dietary intake, secondaryOutcomes measure: Peak Maximal oxygen consumption (Peak VO2), secondaryOutcomes measure: Body Mass, secondaryOutcomes measure: Body Height, secondaryOutcomes measure: Body Fat, secondaryOutcomes measure: Lean body mass, secondaryOutcomes measure: Bone mass density, secondaryOutcomes measure: Bone mass content, secondaryOutcomes measure: Field activity during the soccer training, secondaryOutcomes measure: Heart rate during the soccer training, secondaryOutcomes measure: Systolic Blood Pressure, secondaryOutcomes measure: Dystolic Blood Pressure, secondaryOutcomes measure: Rest Heart Rate, eligibilityModule sex: MALE, minimumAge: 40 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: University o Thessaly, School of Physical Education and Sports Science, status: RECRUITING, city: Tríkala, zip: 42100, country: Greece, contacts name: Athanasios Z Jamurtas, Prof, role: CONTACT, phone: +30 24310 47054, email: ajamurt@pe.uth.gr, contacts name: Ioannis G Fatouros, Prof, role: CONTACT, phone: +30 24310 47047, email: ifatouros@pe.uth.gr, contacts name: Athanasios S Poulios, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 39.55493, lon: 21.76837, hasResults: False

protocolSection identificationModule nctId: NCT06260202, orgStudyIdInfo id: 308.273, briefTitle: Nutrition Under Noninvasive Ventilation, acronym: NUTRINIV, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2024-05-31, completionDateStruct date: 2024-05-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: Università degli Studi del Piemonte Orientale "Amedeo Avogadro", class: OTHER, descriptionModule briefSummary: Even though nutrition is a fundamental component of Intensive care unit (ICU) therapy, critically ill patients are frequently malnourished, a factor well known for its strong association with a higher risk of complications, prolonged ICU/hospital length of stay, and greater ICU readmission and mortality rates. Noninvasive ventilation (NIV) use has increased considerably over the past twenty years, making this supportive technique a keystone of acute respiratory failure (ARF) treatment. In this setting, respiratory support is provided through an interface, usually a mask or a helmet, that frequently represents an important obstacle to nutrition delivery, making oral intake impossible and posing the necessity to start enteral (EN) or parenteral nutrition (PN). Moreover, while critical care guidelines regarding nutritional management of patients receiving mechanical ventilation (MV) are well established, data and recommendations about the appropriate nutritional support to patients in NIV are still very limited. Due to this limited data, we want to describe characteristics and nutritional management of patients undergoing NIV in ICU, and to evaluate the difference between the mean caloric and protein intake of these patients and the recommended caloric and protein target for critically ill patients. Secondarily, we want to evaluate the difference of the caloric and protein intake among groups of patients undergoing different nutritional modality and to assess potential associations of the nutritional characteristics with patient outcomes., conditionsModule conditions: Noninvasive Ventilation, conditions: Nutrition Therapy, conditions: Respiratory Insufficiency, designModule studyType: OBSERVATIONAL, designInfo observationalModel: COHORT, timePerspective: RETROSPECTIVE, enrollmentInfo count: 112, type: ESTIMATED, outcomesModule primaryOutcomes measure: Caloric and protein gap, secondaryOutcomes measure: Nutrition modalities outcomes, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, hasResults: False

protocolSection identificationModule nctId: NCT06260189, orgStudyIdInfo id: Soh-Med-24-01-02MD, briefTitle: Assessment Of Serum And Tissue Levels Of Cold-Inducible RNA-Binding Protein In Patients With Lichen Planus, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2025-02, completionDateStruct date: 2025-10, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Sohag University, class: OTHER, descriptionModule briefSummary: Lichen planus (LP) is a chronic inflammatory mucocutaneous disease of unknown etiology.Pathogenesis of LP is not completely understood, but it's considered a T-cell-mediated autoimmune disease. Cold-inducible RNA binding protein (CIRP or CIRBP) is a member of the glycine-rich RNA-binding protein family, Recent studies proved that CIRP acts as a tumor promoter through its actions on different cellular proliferation levels, Recently, the role of the damage associated molecular proteins and cytokines was highlighted in the pathogenesis of many disorders including psoriasis, alopecia areata, vitiligo, rheumatoid arthritis, other autoimmune diseases as well as several types of cancer. The aim of this study is to compare serum and tissue levels of CIRP in patients with LP and healthy controls., conditionsModule conditions: Assessment, Self, designModule studyType: OBSERVATIONAL, designInfo observationalModel: CASE_CONTROL, timePerspective: CROSS_SECTIONAL, enrollmentInfo count: 80, type: ESTIMATED, armsInterventionsModule, outcomesModule primaryOutcomes measure: Assessment of cold-inducible RNA binding protein levels in serum and tissue, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 60 Years, stdAges: ADULT, contactsLocationsModule locations facility: Aya Ahmed Elsayed, status: RECRUITING, city: Sohag, zip: 82511, country: Egypt, contacts name: Aya A Elsayed, Msc, role: CONTACT, phone: 00201060094631, phoneExt: Egypt, email: aya_shando@yahoo.com, geoPoint lat: 26.55695, lon: 31.69478, hasResults: False

protocolSection identificationModule nctId: NCT06260176, orgStudyIdInfo id: 828722, secondaryIdInfos id: R01DK113307, type: NIH, link: https://reporter.nih.gov/quickSearch/R01DK113307, secondaryIdInfos id: 15163, type: REGISTRY, domain: AsPredicted.org, briefTitle: Vending Labeling Sales and Intercepts Study, statusModule overallStatus: COMPLETED, startDateStruct date: 2019-02-01, primaryCompletionDateStruct date: 2020-03-12, completionDateStruct date: 2020-03-12, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: University of Pennsylvania, class: OTHER, collaborators name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK), descriptionModule briefSummary: The aim of this study is to compare the impact of 4 different types of front of package (FOP) food and beverage messages: 1) green labels on healthy foods, 2) red/yellow/green labels on less healthy/moderately healthy/healthy foods, 3) physical activity calorie equivalent labels, and 4) posters reminding consumers of the sweetened beverage tax on consumers' beverage and snack selections., conditionsModule conditions: Food Preferences, conditions: Obesity, conditions: Weight Gain, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Machine locations were randomly assigned to 1 of 4 front-of-package message arms, stratified by baseline machine sales (high/low) and type of machine location (correctional facilities, courts/offices, large offices, police/fire, recreation centers/libraries/other) with equal probability. The investigators first randomized vending locations (e.g., floors) with beverage machines so that all machines on the same floor displayed the same label. They then randomized the remaining "solo" snack locations. Monthly sales data provided by the City's vending contractor indicated consumer choices. Research assistants also asked a subset of consumers (N=1,065) about their purchases. Intercepts were not allowed in the courts/offices location type and were not conducted at correctional facilities with low traffic. The aim was to collect 10 intercepts per machine visited, distributed over the entire study period, however the study was cut short in March 2020 by the Covid pandemic., primaryPurpose: PREVENTION, maskingInfo masking: NONE, enrollmentInfo count: 1065, type: ACTUAL, armsInterventionsModule interventions name: exposure to healthy labels only, interventions name: exposure to healthiness information, interventions name: exposure to physical activity equivalents, interventions name: exposure to sweetened beverage tax messaging, outcomesModule primaryOutcomes measure: Percentage of beverages sold with calories per month, primaryOutcomes measure: Calories sold from beverages per month, if beverages with calories sold, primaryOutcomes measure: Calories sold from snacks per month, primaryOutcomes measure: Likelihood of selecting a healthy beverage, primaryOutcomes measure: Likelihood of selecting a moderately healthy beverage, primaryOutcomes measure: Likelihood of selecting a less healthy beverage, primaryOutcomes measure: Likelihood of selecting a healthy snack, primaryOutcomes measure: Likelihood of selecting a moderately healthy snack, primaryOutcomes measure: Likelihood of selecting a less healthy snack, primaryOutcomes measure: Total beverage units sold per month per machine., primaryOutcomes measure: Total snack units sold per month per machine, secondaryOutcomes measure: Total revenue per month per beverage machine, secondaryOutcomes measure: Total revenue per month per snack machine, secondaryOutcomes measure: Total calories sold per customer trip, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: University of Pennsylvania, city: Philadelphia, state: Pennsylvania, zip: 19104, country: United States, geoPoint lat: 39.95233, lon: -75.16379, hasResults: False

protocolSection identificationModule nctId: NCT06260163, orgStudyIdInfo id: CR109251, secondaryIdInfos id: 2022-001285-35, type: EUDRACT_NUMBER, secondaryIdInfos id: CNTO1959PUC3001, type: OTHER, domain: Janssen Research & Development, LLC, secondaryIdInfos id: 2022-502238-22-00, type: REGISTRY, domain: EUCT number, briefTitle: A Study of Guselkumab in Pediatric Participants With Moderately to Severely Active Ulcerative Colitis, acronym: QUASAR Jr, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-01-19, primaryCompletionDateStruct date: 2028-05-22, completionDateStruct date: 2028-08-14, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-24, sponsorCollaboratorsModule leadSponsor name: Janssen Research & Development, LLC, class: INDUSTRY, descriptionModule briefSummary: The purpose of this study is to evaluate the efficacy of guselkumab in pediatric participants with moderately to severely active ulcerative colitis at the end of maintenance therapy among participants who were induction responders., conditionsModule conditions: Colitis, Ulcerative, designModule studyType: INTERVENTIONAL, phases: PHASE3, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: INVESTIGATOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Guselkumab Subcutaneous, interventions name: Matching Placebo, interventions name: Guselkumab Intravenous, outcomesModule primaryOutcomes measure: Percentage of Participants with Clinical Remission at Week 56, secondaryOutcomes measure: Percentage of Participants with Clinical Remission at Week 12, secondaryOutcomes measure: Percentage of Participants With Pediatric Ulcerative Colitis Activity Index (PUCAI) Remission at Week 12, secondaryOutcomes measure: Percentage of Participants with Symptomatic Remission at Week 12, secondaryOutcomes measure: United States: Percentage of Participants with Endoscopic Improvement at Week 12, secondaryOutcomes measure: European Union: Percentage of Participants with Endoscopic Healing at Week 12, secondaryOutcomes measure: Percentage of Participants with Clinical Response at Week 12, secondaryOutcomes measure: Percentage of Participants with Symptomatic Remission at Week 56, secondaryOutcomes measure: United States: Percentage of Participants With Endoscopic Improvement at Week 56, secondaryOutcomes measure: European Union: Percentage of Participants With Endoscopic Healing at Week 56, secondaryOutcomes measure: Percentage of Participants with Corticosteroid-free Clinical Remission at Week 56, secondaryOutcomes measure: Percentage of Participants with Clinical Response at Week 56, secondaryOutcomes measure: Percentage of Participants Histo-endoscopic Mucosal Improvement at Week 56, secondaryOutcomes measure: Percentage of Participants with Symptomatic Remission at Week 56 Among Participants who had Symptomatic Remission at Week 12, secondaryOutcomes measure: Percentage of Participants Who Achieve Endoscopic Normalization at Week 56, secondaryOutcomes measure: Percentage of Participants With PUCAI Remission at Week 56, secondaryOutcomes measure: Serum Concentration of Guselkumab During Induction Phase, secondaryOutcomes measure: Serum Concentration of Guselkumab During Maintenance Phase, secondaryOutcomes measure: Number of Participants with Incidence of Anti-guselkumab Antibodies, secondaryOutcomes measure: Percentage of Participants with Adverse Events (AEs), secondaryOutcomes measure: Percentage of Participants with Serious Adverse Events (SAEs), secondaryOutcomes measure: Percentage of Participants with AEs Leading to Discontinuation of Study Intervention, eligibilityModule sex: ALL, minimumAge: 2 Years, maximumAge: 17 Years, stdAges: CHILD, contactsLocationsModule locations facility: Riley Hospital for Children, status: RECRUITING, city: Indianapolis, state: Indiana, zip: 46202, country: United States, geoPoint lat: 39.76838, lon: -86.15804, locations facility: UZ Gent, status: RECRUITING, city: Gent, zip: 9000, country: Belgium, geoPoint lat: 51.05, lon: 3.71667, locations facility: UZ Brussel, status: RECRUITING, city: Jette, zip: 1090, country: Belgium, geoPoint lat: 50.87309, lon: 4.33419, locations facility: Capital Institute of Pediatrics, status: RECRUITING, city: Beijing, zip: 100020, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Peking University Third Hospital, status: RECRUITING, city: Beijing, zip: 100191, country: China, geoPoint lat: 39.9075, lon: 116.39723, locations facility: Changzhou No 2 Peoples Hospital, status: RECRUITING, city: Changzhou City, zip: 213004, country: China, locations facility: The Childrens Hospital Zhejiang University School Of Medicine, status: RECRUITING, city: Hangzhou, zip: 310005, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Sir Run Run Shaw Hospital, Zhejiang University School of Medicine, status: RECRUITING, city: Hangzhou, zip: 310016, country: China, geoPoint lat: 30.29365, lon: 120.16142, locations facility: Ruijin Hospital, Shanghai Jiao Tong University, status: RECRUITING, city: Shanghai, zip: 200025, country: China, geoPoint lat: 31.22222, lon: 121.45806, locations facility: Shengjing Hospital of China Medical University, status: RECRUITING, city: Shenyang, zip: 110004, country: China, geoPoint lat: 41.79222, lon: 123.43278, locations facility: Hvidovre Hospital, status: RECRUITING, city: Hvidovre, zip: 2650, country: Denmark, geoPoint lat: 55.65719, lon: 12.47364, locations facility: AOU Policlinico Umberto I, status: RECRUITING, city: Roma, zip: 00161, country: Italy, geoPoint lat: 41.89193, lon: 12.51133, locations facility: Kanazawa University Hospital, status: RECRUITING, city: Kanazawa, zip: 920-8641, country: Japan, geoPoint lat: 36.6, lon: 136.61667, locations facility: Kobe University Hospital, status: RECRUITING, city: Kobe, zip: 650-0017, country: Japan, geoPoint lat: 34.6913, lon: 135.183, locations facility: Japanese Red Cross Kumamoto Hospital, status: RECRUITING, city: Kumamoto, zip: 861-8520, country: Japan, geoPoint lat: 32.80589, lon: 130.69182, locations facility: Shinshu University Hospital, status: RECRUITING, city: Matsumoto, zip: 390-8621, country: Japan, geoPoint lat: 36.23333, lon: 137.96667, locations facility: Saga University Hospital, status: RECRUITING, city: Saga, zip: 849-8501, country: Japan, geoPoint lat: 33.23333, lon: 130.3, locations facility: Tokyo Medical University Hospital, status: RECRUITING, city: Shinjuku, zip: 160-0023, country: Japan, geoPoint lat: 35.2946, lon: 139.57059, locations facility: Osaka Medical and Pharmaceutical University Hospital, status: RECRUITING, city: Takatsuki, zip: 569-8686, country: Japan, geoPoint lat: 34.84833, lon: 135.61678, locations facility: Saiseikai Yokohamashi Tobu Hospital, status: RECRUITING, city: Yokohama, zip: 230-8765, country: Japan, geoPoint lat: 35.43333, lon: 139.65, locations facility: Korczowski Bartosz Gabinet Lekarski, status: RECRUITING, city: Rzeszow, zip: 35-302, country: Poland, geoPoint lat: 50.04132, lon: 21.99901, locations facility: Medical Network Spolka z o.o. WIP Warsaw IBD Point Profesor Kierkus, status: RECRUITING, city: Warszawa, zip: 04 501, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Instytut Pomnik Centrum Zdrowia Dziecka, status: RECRUITING, city: Warszawa, zip: 04 730, country: Poland, geoPoint lat: 52.22977, lon: 21.01178, locations facility: Gazi University Medical Faculty, status: RECRUITING, city: Ankara, zip: 06560, country: Turkey, geoPoint lat: 39.91987, lon: 32.85427, hasResults: False

protocolSection identificationModule nctId: NCT06260150, orgStudyIdInfo id: ZXT, briefTitle: Application of IPC During Surgery to Prevent Venous Thrombosis in Gastrointestinal Surgery Patients., statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-04-01, primaryCompletionDateStruct date: 2024-04, completionDateStruct date: 2024-04, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Feng Tian, class: OTHER_GOV, descriptionModule briefSummary: The goal of this clinical trial is to evaluate the effectiveness of intraoperative intermittent pneumatic compression (IPC) device usage in preventing lower extremity deep vein thrombosis (DVT) in patients undergoing gastrointestinal surgery.The main question it aims to answer is provide a reference basis for determining the efficacy of IPC application during gastrointestinal surgery for preventing lower extremity DVT in patients.Participants are patients who require gastrointestinal surgery, specifically for the resection of gastrointestinal tumors. They will be divided into a control group and an experimental group. The experimental group will use an Intermittent Pneumatic Compression (IPC) device during surgery, while the control group will receive standard treatment. The objective is to observe whether the use of IPC during surgery can prevent the formation of Deep Vein Thrombosis (DVT) or lower the Risk of DVT., conditionsModule conditions: Gastrointestinal Neoplasms, conditions: Stomach Neoplasms, conditions: Intestinal Neoplasms, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 120, type: ESTIMATED, armsInterventionsModule interventions name: Intermittent Pneumatic Compression Devices, outcomesModule primaryOutcomes measure: Incidence rate of DVT, secondaryOutcomes measure: Length of surgery, secondaryOutcomes measure: Intraoperative body temperature, secondaryOutcomes measure: Amount of bleeding during surgery, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 99 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Shandong Provincial Hospital, city: Jinan, state: Shandong, zip: 250021, country: China, geoPoint lat: 36.66833, lon: 116.99722, hasResults: False

protocolSection identificationModule nctId: NCT06260137, orgStudyIdInfo id: UludagThorax, briefTitle: Comparison of Two Different Methods for Reducing Pain After Lung Surgery, statusModule overallStatus: ACTIVE_NOT_RECRUITING, startDateStruct date: 2023-07-10, primaryCompletionDateStruct date: 2024-07, completionDateStruct date: 2024-08, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Uludag University, class: OTHER, descriptionModule briefSummary: The goal of this clinical study is to compare the effectiveness of the Rhomboid Intercostal Block and Sub-Servitus plan block and the effectiveness of the Rhomboid intercostal block in patients with video-supported thoracoscopic surgery. The main question it aims to answer is:Which of these two blocks more effectively reduces the patients' pain?, conditionsModule conditions: Postoperative Analgesia, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: OTHER, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 60, type: ESTIMATED, armsInterventionsModule interventions name: Rhomboid intercostal block, interventions name: Rhomboid intercostal and subserratus plane block, outcomesModule primaryOutcomes measure: Postoperative analgesia, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Hastane, city: Bursa, zip: 16210, country: Turkey, geoPoint lat: 40.19559, lon: 29.06013, hasResults: False

protocolSection identificationModule nctId: NCT06260124, orgStudyIdInfo id: Greek Dancing-UTH, briefTitle: Acute Physiological Effects of Greek Traditional Dancing, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2024-06-30, completionDateStruct date: 2024-10-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-09, sponsorCollaboratorsModule leadSponsor name: University of Thessaly, class: OTHER, descriptionModule briefSummary: In Greece, people of different age groups, including young children to older adults, are involved in traditional dance. To date, the well-know benefits of dancing include entertainment, socialization and increased physical activity. However, the acute effects of Greek traditional dancing on health, physical performance and muscle damage indices remain largely unknown. Therefore, the aim of this project is to evaluate the acute effect of Greek traditional dancing on health-, physical performance-, and muscle damage-related parameters by considering the impact of dancing tempo (slow vs moderate vs fast). In a crossover repeated measures design 10 pre- and 10 post-menopausal women will participate in the three dancing sessions of different tempo in a random order., conditionsModule conditions: Menopause, conditions: Cardiovascular Health, conditions: Body Composition, conditions: Physical Performance, conditions: Muscle Damage, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: CROSSOVER, primaryPurpose: BASIC_SCIENCE, maskingInfo masking: NONE, enrollmentInfo count: 20, type: ESTIMATED, armsInterventionsModule interventions name: Slow tempo, interventions name: Moderate tempo, interventions name: Fast tempo, outcomesModule primaryOutcomes measure: Change in blood pressure, primaryOutcomes measure: Change in perceived exertion, primaryOutcomes measure: Change in blood lactate, primaryOutcomes measure: Change in resting metabolic rate, primaryOutcomes measure: Change in delayed-onset of muscle soreness (DOMS), primaryOutcomes measure: Change in maximal isometric voluntary contraction, primaryOutcomes measure: Change in joint range of motion, primaryOutcomes measure: Change in functional performance, primaryOutcomes measure: Change in white blood cell count, primaryOutcomes measure: Change in granulocyte count, primaryOutcomes measure: Change in lymphocytes, primaryOutcomes measure: Change in monocytes, primaryOutcomes measure: Change in creatine kinase concentration, primaryOutcomes measure: Change in reduced glutathione, primaryOutcomes measure: Change in oxidized glutathione, primaryOutcomes measure: Change in catalase activity, primaryOutcomes measure: Change in protein carbonyls, primaryOutcomes measure: Change in total antioxidant capacity, primaryOutcomes measure: Change in heart rate, primaryOutcomes measure: Change in oxygen consumption, primaryOutcomes measure: Change in physical activity, secondaryOutcomes measure: Change in red blood cell count, secondaryOutcomes measure: Change in hematocrit, secondaryOutcomes measure: Change in hemoglobin, eligibilityModule sex: FEMALE, minimumAge: 20 Years, maximumAge: 80 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule, hasResults: False

protocolSection identificationModule nctId: NCT06260111, orgStudyIdInfo id: SA23I0021, briefTitle: Photobiomodulation for Oral Mucositis and Functional Impairments During Hematopoietic Stem Cell Transplantation, acronym: POMFITT, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-04-10, primaryCompletionDateStruct date: 2025-10-30, completionDateStruct date: 2025-10-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Universidad del Desarrollo, class: OTHER, collaborators name: Agencia Nacional de Investigación y Desarrollo, collaborators name: Clínica Dávila, descriptionModule briefSummary: The goal of this clinical trial is to test the efficacy of laser photobiomodulation in adult hematologic cancer patients undergoing hematopoietic stem cell transplantation (HSCT). The main questions it aims to answer are: • Is photobiomodulation with laser in the oral cavity, compared to standard care, effective in preventing oral mucositis and functional impairments in adult patients receiving HSCT? • What is the level of patient´s acceptability of photobiomodulation with laser in the oral cavity during HSCT? Participants once a day will receive photobiomodulation (diode laser device) in their oral cavity from the first day of transplantation conditioning until third day post-transplant. Researchers will compare with usual care to see if photobiomodulation helps preventing oral mucositis and functional impairment., conditionsModule conditions: Hematologic Cancer, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: The design of the study consists of a randomized, controlled trial with parallel groups (photobiomodulation + usual care versus a control group with only usual care), allocation ratio of 1:1., primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, maskingDescription: Assessor will be blinded only for the secondary outcomes. The person responsible for statistical analyses will also be blinded., whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 30, type: ESTIMATED, armsInterventionsModule interventions name: Photobiomodulation, interventions name: Usual care, outcomesModule primaryOutcomes measure: Oral Mucositis, primaryOutcomes measure: Level of Pain, secondaryOutcomes measure: Handgrip strength, secondaryOutcomes measure: Exercise tolerance, secondaryOutcomes measure: Physical fitness, secondaryOutcomes measure: Health related quality of life, secondaryOutcomes measure: Length of hospital stay, secondaryOutcomes measure: Use of opioids, secondaryOutcomes measure: Body mass index, secondaryOutcomes measure: Nutritional status, secondaryOutcomes measure: Daily calorie intake, secondaryOutcomes measure: Arm circumference, secondaryOutcomes measure: Triceps skinfold, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 70 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Clinica Dávila, city: Santiago, state: Metropolitana, zip: 8431657, country: Chile, contacts name: Tomás A López-Espinoza, MSc.C., role: CONTACT, phone: +56962056755, email: tlopeze@udd.cl, contacts name: Hernán López, MD, role: CONTACT, phone: +56966795985, email: hernan.lopez@davila.cl, contacts name: Monica Peña, Nurse, role: SUB_INVESTIGATOR, geoPoint lat: -33.45694, lon: -70.64827, hasResults: False

protocolSection identificationModule nctId: NCT06260098, orgStudyIdInfo id: H23-0617, briefTitle: StressLess Yoga Study, statusModule overallStatus: RECRUITING, startDateStruct date: 2024-04-03, primaryCompletionDateStruct date: 2024-05-30, completionDateStruct date: 2024-05-30, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-04-05, sponsorCollaboratorsModule leadSponsor name: University of Connecticut, class: OTHER, descriptionModule briefSummary: The purpose of this study is to assess the feasibility and acceptability of using an asynchronous online yoga program to reduce stress. The study will use an 8 week asynchronous yoga intervention of two different types of yoga (high in breath work and meditation; low in vigorous movement/postures vs. low breath work and meditation; high movement/postures). In addition to self-report stress, measures include sleep, heart rate variability, mindfulness, Essential Properties of Yoga, and acceptability questions., conditionsModule conditions: Stress, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: SINGLE, whoMasked: PARTICIPANT, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Yoga with High Breath work & meditation; Low movement/postures, interventions name: Yoga with Low Breath work & meditation; High movement/postures, outcomesModule primaryOutcomes measure: The number (percentage)of people completing the whole protocol (6/8 yoga classes & 2 in-person visits), primaryOutcomes measure: The combined score (out of 35) on the 5-item Treatment Acceptability Questionnaire (TAQ), eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Bousfield Psychology Building, 406 Babbidge Road, status: RECRUITING, city: Storrs, state: Connecticut, zip: 06269, country: United States, contacts name: Crystal Park, PhD, role: CONTACT, phone: 860-486-3520, email: crystal.park@uconn.edu, contacts name: Crystal Park, PhD, role: PRINCIPAL_INVESTIGATOR, geoPoint lat: 41.80843, lon: -72.24952, hasResults: False

protocolSection identificationModule nctId: NCT06260085, orgStudyIdInfo id: 686, briefTitle: Effect of Listening to Relatives' Voice Recordings on Chest Pain, Anxiety, and Depression in Coronary ICU Patients, statusModule overallStatus: COMPLETED, startDateStruct date: 2022-06-04, primaryCompletionDateStruct date: 2023-07-04, completionDateStruct date: 2023-09-04, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: T.C. ORDU ÜNİVERSİTESİ, class: OTHER, descriptionModule briefSummary: The aim of the study was to evaluate the effect of listening to the voice recordings of relatives of patients with acute myocardial infarction (AMI) who were treated in the coronary intensive care unit on chest pain, anxiety and depression parameters of the patients.Methods In the study, which was conducted as a randomised, controlled, experimental study, voice recordings of the family members of the patients were created and played to the patients through a music pillow. The study was carried out with 60 patients, 30 experimental and 30 control groups. Three tests were applied to the patients 15 minutes before, 15 and 30 minutes after the application. The data of the study were collected using the "Patient Introduction Form", "Hospital Anxiety Depression Scale", "Visual Analogue Scale" and "Patient Follow-up Form"., conditionsModule conditions: Acute Myocardial Infarction, conditions: Intensive Care Unit Syndrome, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: SINGLE, maskingDescription: The clinical nurse collected the data, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 60, type: ACTUAL, armsInterventionsModule interventions name: Relatives vioce record, outcomesModule primaryOutcomes measure: Chest Pain, secondaryOutcomes measure: Anxiety, and Depression, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Yasemin Kalkan Uğurlu, city: Ordu, zip: 52200, country: Turkey, geoPoint lat: 40.97782, lon: 37.89047, hasResults: False

protocolSection identificationModule nctId: NCT06260072, orgStudyIdInfo id: IRB-HSR 21920, briefTitle: Magnesium and Riboflavin Treatment for Post-Concussion Headache, statusModule overallStatus: RECRUITING, startDateStruct date: 2020-02-10, primaryCompletionDateStruct date: 2024-12-31, completionDateStruct date: 2024-12-31, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-16, sponsorCollaboratorsModule leadSponsor name: University of Virginia, class: OTHER, descriptionModule briefSummary: This clinical trial will try to determine if the supplements magnesium and riboflavin will reduce the pain and duration of headaches in persons diagnosed with a concussion. The participant will be randomized to either active magnesium and riboflavin capsules or placebo (inert) capsules. The capsules will be taken once a day for 14 days. The participant will also complete a short diary form for the 14 days and will have 3 follow up visits either by telephone or in person., conditionsModule conditions: Concussion, Intermediate, designModule studyType: INTERVENTIONAL, phases: PHASE2, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: TREATMENT, maskingInfo masking: TRIPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, enrollmentInfo count: 108, type: ESTIMATED, armsInterventionsModule interventions name: magnesium and riboflavin supplement, outcomesModule primaryOutcomes measure: Headache Intensity and Duration, eligibilityModule sex: ALL, minimumAge: 18 Years, maximumAge: 40 Years, stdAges: ADULT, contactsLocationsModule locations facility: University of Virginia Student Health and Wellness Center, status: RECRUITING, city: Charlottesville, state: Virginia, zip: 22903, country: United States, contacts name: Karen Ahern, BSN MBA, role: CONTACT, phone: 434-924-1549, email: kaa7p@virginia.edu, geoPoint lat: 38.02931, lon: -78.47668, hasResults: False

protocolSection identificationModule nctId: NCT06260059, orgStudyIdInfo id: STUDY23070148, secondaryIdInfos id: Pitt2024, type: OTHER_GRANT, domain: Pittsburgh Foundation, briefTitle: Efficacy Of Sodium Glucose Transporter Inhibitor (SGLT2I) In Adult Patients With Congenital Heart Disease, acronym: EmpaCHD, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-02, primaryCompletionDateStruct date: 2026-12-31, completionDateStruct date: 2027-06-01, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Anita Saraf, class: OTHER, collaborators name: The Pittsburgh Foundation, descriptionModule briefSummary: The goal of the study is to investigate the feasibility and benefit of novel guideline-directed heart failure therapy drug Empagliflozin (Jardiance) for adult patients with congenital heart disease (ACHD)., conditionsModule conditions: Adult Congenital Heart Disease, conditions: Heart Failure, designModule studyType: INTERVENTIONAL, phases: PHASE4, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, interventionModelDescription: Group 1: Empagliflozin 10 MG daily Group 2: Placebo, primaryPurpose: TREATMENT, maskingInfo masking: QUADRUPLE, whoMasked: PARTICIPANT, whoMasked: CARE_PROVIDER, whoMasked: INVESTIGATOR, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 40, type: ESTIMATED, armsInterventionsModule interventions name: Empagliflozin 10 MG, interventions name: Placebo, outcomesModule primaryOutcomes measure: Change in Ejection fraction (EF), primaryOutcomes measure: Change in Myocardial characteristics (T1 mapping of cMRI), primaryOutcomes measure: Change in Myocardial characteristics (Global strain on MRI), primaryOutcomes measure: Change in Myocardial characteristics (Global strain on echocardiogram), primaryOutcomes measure: Change in functional exercise capacity of participants., primaryOutcomes measure: Number of Participants Hospitalized for Cardiac Reasons or heart transplantation, primaryOutcomes measure: Number of Deaths, secondaryOutcomes measure: Change in inflammatory serum biomarkers, secondaryOutcomes measure: Change in functional Neuropsychological Testing, secondaryOutcomes measure: Change in New York Heart Association (NYHA) Class, secondaryOutcomes measure: Change Patient-Reported Outcomes Measurement Information System (PROMIS), secondaryOutcomes measure: Change in Kansas City Cardiomyopathy (KCCQ), secondaryOutcomes measure: Change in Neuro-QOL, eligibilityModule sex: ALL, minimumAge: 18 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Magee Women's Hospital, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Presbyterian Hospital, city: Pittsburgh, state: Pennsylvania, zip: 15213, country: United States, geoPoint lat: 40.44062, lon: -79.99589, locations facility: Children's Hospital of Pittsburgh, city: Pittsburgh, state: Pennsylvania, zip: 15224, country: United States, geoPoint lat: 40.44062, lon: -79.99589, hasResults: False

protocolSection identificationModule nctId: NCT06260046, orgStudyIdInfo id: Robot Nx-SFTN, briefTitle: Effect of Sufentanil on the Postoperative Pain, statusModule overallStatus: NOT_YET_RECRUITING, startDateStruct date: 2024-03-01, primaryCompletionDateStruct date: 2025-01-15, completionDateStruct date: 2027-01-15, studyFirstPostDateStruct date: 2024-02-15, lastUpdatePostDateStruct date: 2024-02-15, sponsorCollaboratorsModule leadSponsor name: Seoul National University Hospital, class: OTHER, descriptionModule briefSummary: This study is a randomized, controlled trial. A total of 48 patients will be randomized to receive sufentanil or remifentanil during robot-assisted nephrectomy surgery., conditionsModule conditions: Postoperative Pain, Acute, designModule studyType: INTERVENTIONAL, phases: NA, designInfo allocation: RANDOMIZED, interventionModel: PARALLEL, primaryPurpose: PREVENTION, maskingInfo masking: DOUBLE, whoMasked: PARTICIPANT, whoMasked: OUTCOMES_ASSESSOR, enrollmentInfo count: 48, type: ESTIMATED, armsInterventionsModule interventions name: Sufentanil, interventions name: Remifentanil, outcomesModule primaryOutcomes measure: opioid consumption, secondaryOutcomes measure: Richmond Agitation-Sedation scale, secondaryOutcomes measure: Incidence of postoperative nausea and vomiting, secondaryOutcomes measure: Number of patients who administered antiemetics, secondaryOutcomes measure: Pain score, eligibilityModule sex: ALL, minimumAge: 19 Years, stdAges: ADULT, stdAges: OLDER_ADULT, contactsLocationsModule locations facility: Seoul National University Bundang Hospital, city: Seongnam, country: Korea, Republic of, contacts name: Chang-Hoon Koo, role: CONTACT, email: vollock9@gmail.com, geoPoint lat: 37.43861, lon: 127.13778, hasResults: False